Modular intraocular lens designs, tools and methods

ABSTRACT

Modular IOL removal systems and methods that cut an optic portion of an intraocular in a single motion such to facilitate removal of the optic portion from an eye through an incision, for example a corneal incision, without increasing the size of the corneal incision. Various cutting tools having one or more blades may be utilized. The cut intraocular lens may have one continuous cut or be cut into multiple smaller pieces. The single cutting step may apply balanced forces and torque to avoid damaging the surrounding eye anatomy, reducing the risk of trauma.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefits under 35 U.S.C. § 119(e) ofpriority to U.S. Provisional Patent Application No. 61/941,167, filedFeb. 18, 2014, entitled “MODULAR INTRAOCULAR LENS DESIGNS, TOOLS ANDMETHODS,” the entirety of which is incorporated herein by reference.This application is related to U.S. patent application Ser. No.13/969,115, filed Aug. 16, 2013, entitled “MODULAR INTRAOCULAR LENSDESIGNS & METHODS,” which claims the benefits under 35 U.S.C. § 119(e)of priority to U.S. Provisional Patent Application No. 61/830,491, filedJun. 3, 2013, entitled “MODULAR INTRAOCULAR LENS DESIGNS AND METHODS,”each of which is incorporated herein by reference. This application alsois related to U.S. patent application Ser. No. 13/748,207, filed Jan.23, 2013, entitled “MODULAR INTRAOCULAR LENS DESIGNS & METHODS,” whichclaims the benefits under 35 U.S.C. § 119(e) of priority of U.S.Provisional Patent Application No. 61/589,981, filed on Jan. 24, 2012,entitled “LASER ETCHING OF IN SITU INTRAOCULAR LENS AND SUCCESSIVESECONDARY LENS IMPLANTATION,” and of U.S. Provisional Patent ApplicationNo. 61/677,213, filed on Jul. 30, 2012, entitled “MODULAR INTRAOCULARLENS DESIGNS & METHODS,” each of which is incorporated herein byreference.

FIELD OF THE INVENTION

The present disclosure generally relates to intraocular lenses (IOLs).More specifically, the present disclosure relates to embodiments ofmodular IOL designs, methods and associated tools.

BACKGROUND

The human eye functions to provide vision by transmitting light througha clear outer portion called the cornea, and focusing the image by wayof a crystalline lens onto a retina. The quality of the focused imagedepends on many factors including the size and shape of the eye, and thetransparency of the cornea and the lens.

When age or disease causes the lens to become less transparent (e.g.,cloudy), vision deteriorates because of the diminished light, which canbe transmitted to the retina. This deficiency in the lens of the eye ismedically known as a cataract. An accepted treatment for this conditionis surgical removal of the lens from the capsular bag and placement ofan artificial intraocular lens (IOL) in the capsular bag. In the UnitedStates, the majority of cataractous lenses are removed by a surgicaltechnique called phacoemulsification. During this procedure, an opening(capsulorhexis) is made in the anterior side of the capsular bag and athin phacoemulsification-cutting tip is inserted into the diseased lensand vibrated ultrasonically. The vibrating cutting tip liquefies oremulsifies the lens so that the lens may be aspirated out of thecapsular bag. The diseased lens, once removed, is replaced by an IOL.

After cataract surgery to implant an IOL, the optical result may besuboptimal or may need adjustment over time. For example, shortly afterthe procedure, it may be determined that the refractive correction iserroneous leading to what is sometimes called “refractive surprise.”Also for example, long after the procedure, it may be determined thatthe patient needs or desires a different correction, such as a strongerrefractive correction, an astigmatism correction, or a multifocalcorrection.

In each of these cases, a surgeon may be reluctant to attempt removal ofthe suboptimal IOL from the capsular bag and replacement with a new IOL.In general, manipulation of the capsular bag to remove an IOL risksdamage to the capsular bag including posterior rupture. This riskincreases over time as the capsular bag collapses around the IOL andtissue ingrowth surrounds the haptics of the IOL. Thus, it would bedesirable to be able to correct or modify the optical result without theneed to remove the IOL or manipulate the capsular bag.

A variety of secondary lenses have been proposed to address theaforementioned drawbacks. For example, one possible solution includes asecondary lens that resides anterior to the capsular bag with hapticsthat engage the ciliary sulcus. While this design may have the advantageof avoiding manipulation of the capsular bag, its primary disadvantageis engaging the ciliary sulcus. The ciliary sulcus is composed of softvascularized tissue that is susceptible to injury when engaged byhaptics or other materials. Such injury may result in complications suchas bleeding, inflammation and hyphema. Thus, in general, it may bedesirable to avoid placing a secondary lens in the ciliary sulcus toavoid the potential for complications.

Another potential solution may include a lens system that avoids thepotential problems associated with the ciliary sulcus. The lens systemmay include a primary lens and a secondary lens, where the secondarylens may be attached to the primary lens, both within the capsular bag.The primary lens may have a recess into which an edge of the secondarylens may be inserted for attachment. The recess is preferably locatedradially outwardly of the opening (capsulorhexis) in the capsular bag toavoid interfering with light transmission. To attach the secondary lensin-situ, the capsular bag must be manipulated around the perimeter ofthe capsulorhexis to gain access to the recess in the primary lens. Asstated previously, manipulation of the capsular bag may be undesirablegiven the risks associated therewith. Therefore, while such lens systemsmay avoid the potential for injury to the ciliary sulcus by implantingboth the primary lens and the secondary lens in the capsular bag, thesesystems do not avoid manipulation of the capsular bag to attach thesecondary lens.

Thus, there remains a need for an IOL system and method that allows forcorrection or modification of the optical result using a lens that canbe attached to a base or primary lens without the need manipulate thecapsular bag.

SUMMARY OF THE INVENTION

Embodiments of the present disclosure provide a modular IOL systemincluding intraocular primary and secondary components, which, whencombined, form an intraocular optical correction device. The primarycomponent may comprise an intraocular base, and the secondary componentmay comprise an intraocular lens, wherein the base is configured toreleasably receive the intraocular lens. In some embodiments, the basemay be configured as a lens, in which case the modular IOL system may bedescribed as including a primary lens and a secondary lens. The primarycomponent (e.g., base or primary lens) may be placed in the capsular bagusing conventional cataract surgery techniques. The primary componentmay have a diameter greater than the diameter of the capsulorhexis toretain the primary component in the capsular bag. The secondarycomponent (e.g., secondary lens) may have a diameter less than thediameter of the capsulorhexis such that the secondary component may beattached to the primary component without manipulation of the capsularbag. The secondary component may also be manipulated to correct ormodify the optical result, intra-operatively or post-operatively,without the need to remove the primary component and without the need tomanipulate the capsular bag. For example, the secondary component may beremoved, repositioned, and/or exchanged to correct, modify, and/or finetune the optical result.

Common indications for exchanging the secondary component may beresidual refractive error (e.g., for monofocal lenses), decentrationerror (e.g., for multifocal lenses) due to post-operative healing,astigmatism error (e.g., for toric lenses) induced by surgery, changingoptical correction needs due to progressive disease, changing opticalcorrection desires due to lifestyle changes, injury, age, etc.

The primary component may have haptics (e.g., projections) extendingtherefrom for centration in the capsular bag, and the secondarycomponent may exclude haptics, relying instead on attachment to theprimary component for stability. The secondary component may resideradially inside the perimeter of the capsulorhexis, thereby negating theneed to disturb the capsular bag to manipulate or exchange the secondarycomponent. The attachment between the primary component and thesecondary component may reside radially inside the perimeter of thecapsulorhexis and radially outside the field of view to avoidinterference with light transmission. Alternatively or in addition, theattachment may comprise a small fraction of the perimeter (e.g., lessthan 20%) of the secondary component to minimize the potential forinterference in light transmission.

The primary component may have an anterior surface that is in intimatecontact with a posterior surface of the secondary component to preventfluid ingress, tissue ingrowth, and/or optical interference. Thesecondary component may be removably secured to the primary component bymechanical attachment and/or chemical attraction, for example.Mechanical attachment may be facilitated by mating or interlockinggeometries corresponding to each of the primary and the secondarycomponents. Such geometries may be pre-formed by molding or cutting, forexample, or formed in-situ by laser etching, for example. Chemicalattraction may be facilitated by using similar materials with a smoothsurface finish activated by a surface treatment, for example. In someinstances, it may be desirable to reduce chemical attraction and relymore on mechanical attachment for stability. In this case, the primaryand secondary components may be formed of dissimilar materials orotherwise have adjacent surfaces that do not have a chemical attraction.

Generally, the primary component (base or primary lens) may be deliveredin a rolled configuration using a delivery tube inserted through acorneal or scleral incision, through the capsulorhexis and into thecapsular bag. The primary component may be ejected from the deliverytube and allowed to unfurl inside the capsular bag. The secondarycomponent (lens) may also be delivered in a rolled configuration viaejection from a delivery tube and allowed to unfurl anterior to theprimary component. With gentle manipulation, the secondary component maybe centered on the primary component and attached thereto via anattachment mechanism.

The secondary component may be removed and exchanged for a replacementsecondary component, such as a replacement lens with a different opticalcorrection. Initially, the secondary component may be disconnected fromthe primary component to reside anteriorly to the primary component. Thesecondary component may be removed from the eye via the same cornealincision used to implant the modular IOL without increasing the size ofthe incision. This may be accomplished by either folding the secondarycomponent prior to removal through the incision or by cutting thesecondary component such that it has a smaller width than the incision.A cannula or delivery tube may be used to facilitate this removal. TheIOL may be removed as a single piece or in multiple pieces.

The cutting removal methods may utilize one continuous cut path ormultiple cut paths. A surgical cutting tool may be employed to createthe various cut patterns. The cut path or paths may be linear ornonlinear. The cutting step may be simultaneous with the removal step.For example, the secondary component may be cut as it is extractedthrough a cannula.

The surgical cutting tools and removal methods may apply balanced forcesand/or torques on the secondary lens to minimize movement thereof duringcutting. This minimizes or avoids anterior-posterior forces on thecapsular bag and prevents capsular rupture. The removal methods mayavoid flexing the secondary lens (“tenting”) and/or rotating thesecondary lens in the anterior-posterior direction, again to avoidtrauma to the capsular bag. The cut may be a “clean cut” so as to avoidgenerating small fragments, debris or jagged edges.

In one embodiment, a cutting instrument may be used to cut the secondarylens into two or more pieces. The cut pattern may be horseshoe-shaped,for example. The cutting instrument may be a scissors-like punch.Alternatively, the cutting instrument may include a retractable cuttingbase configured to extend either above or below the secondary lens. Thecutting instrument may also include a dual-edge blade having two cuttingsurfaces configured to pinch the secondary lens against the retractablecutting base. As the cutting base retracts into the cutting instrument,the dual edge blade may cut the secondary lens along the face of thesecondary lens opposite to the cutting base. Alternatively, the dualedge blades may extend towards the cutting base, cutting the secondarylens as it extends.

In a related embodiment, an extendable grasper may replace the cuttingbase such that the secondary lens is secured along the length of the cutpath during the cutting step. During the cutting step, the dual edgeblades extend towards the grasper cutting the secondary lens.

In another embodiment, a cutting instrument may be used to cut a curved“spiral” or “J-shape” cut pattern in the secondary lens. The cuttinginstrument may be scissors-like with curved blades. The cut secondarylens may spin or “spiral” as it is pulled through the corneal incisionor cannula.

In another embodiment, the secondary lens may be cut as it is removedfrom the anterior chamber. A cannula having a distal cutting surface maybe inserted through the corneal incision and into the anterior chamberof the eye. A forceps or other appropriate grasping tool may extendthrough the cannula, grasp the edge of the secondary lens, and pull thesecondary lens into the cannula. As the secondary lens is pulled intothe cannula, it passes the cutting surface and is cut or “peeled.” Thesecondary lens may spin as it is pulled into the cannula and removedfrom the anterior chamber of the eye through the corneal incision.

The modular IOL systems, tools and methods according to embodiments ofthe present disclosure may be applied to a variety of IOL types,including fixed monofocal, multifocal, toric, accommodative, andcombinations thereof. In addition, the modular IOL systems, tools andmethods according to embodiments of the present disclosure may be usedto treat, for example: cataracts, large optical errors in myopic(near-sighted), hyperopic (far-sighted), and astigmatic eyes, ectopialentis, aphakia, pseudophakia, and nuclear sclerosis.

Various other aspects of embodiments of the present disclosure aredescribed in the following detailed description and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate example embodiments of the present disclosure.The drawings are not necessarily to scale, may include similar elementsthat are numbered the same, and may include dimensions (in millimeters)and angles (in degrees) by way of example, not necessarily limitation.In the drawings:

FIG. 1 is a schematic diagram of the human eye shown in cross section;

FIGS. 2A and 2B are front and side cross-sectional views, respectively,of a modular IOL disposed in a capsular bag according to an embodimentof the present disclosure;

FIGS. 3A-3D and 4A-4D are front and side cross-sectional views,respectively, schematically illustrating a method for implanting amodular IOL according to an embodiment of the present disclosure;

FIG. 5 is a front view of a modular IOL, according to an embodiment ofthe present disclosure, wherein subsurface attachment mechanisms areprovided for connection between the primary and secondary lenses;

FIGS. 6A and 6B are cross-sectional views taken along line 6-6 in FIG.5, showing two embodiments of subsurface attachment mechanisms;

FIG. 7 is a front view of a modular IOL, according to an embodiment ofthe present disclosure, wherein extension attachment mechanisms areprovided to connect the primary and secondary lenses;

FIGS. 8A-8C are cross-sectional views taken along line 8-8 in FIG. 7,showing three embodiments of extension attachment mechanisms;

FIGS. 9A-9D are front views showing various positions of the attachmentmechanisms to adjust the position of the secondary lens relative to theprimary lens;

FIG. 10 is a front view of a modular IOL, according to an embodiment ofthe present disclosure, wherein etched subsurface attachment mechanismsare provided for connection between the primary and secondary lenses;

FIGS. 11A-11F are cross-sectional views of the modular IOL shown in FIG.10, showing various embodiments of etched subsurface attachmentmechanisms;

FIGS. 12A-12C are schematic illustrations of front, sectional and detailviews, respectively, of an alternative modular IOL, according to anembodiment of the present disclosure;

FIGS. 13A and 13B show representative photomicrographs at 4× and 40×magnification, respectively, of a groove (see, arrow) formed by laseretching;

FIGS. 14, 14A-14C, 15, 15A-15D, 16, 16A-16D, 17, 17A-17C, 18, 18A-18C,19, 19A-19D, 20, 20A-20I, 21, 21A-21E, 22, and 22A-22D are various viewsof alternative modular IOLs according to embodiments of the presentdisclosure;

FIGS. 23A-23D are schematic illustrations of a lens removal system for amodular IOL according to an embodiment of the present disclosure;

FIGS. 23E-23H are schematic illustrations of an alternative embodimentof a lens removal system for a modular IOL;

FIG. 24 is a schematic flow chart of a method for using a modular IOL,according to an embodiment of the present disclosure, wherein anexchange of the secondary lens is motivated by a sub-optimal opticalresult detected intra-operatively;

FIG. 25 is a schematic flow chart of a method for using a modular IOL,according to an embodiment of the present disclosure, wherein anexchange of the secondary lens is motivated by a sub-optimal opticalresult detected post-operatively;

FIG. 26 is a schematic flow chart of a method for using a modular IOL,according to an embodiment of the present disclosure, wherein asecondary lens is attached to a primary lens by forming the attachmentmeans in-situ;

FIGS. 27, 27A-27D, 28A-28G, and 29A-29F are various views of furtheralternative embodiments of modular IOLs, according to the presentdisclosure;

FIGS. 29A2-29E2 various views of further alternative embodiments ofmodular IOLs, according to the present disclosure;

FIGS. 29G-29M are anatomical views showing insertion and removal of amodular IOL into an eye;

FIGS. 30A and 30B are various views of a further embodiments of modularIOLs, according to the present disclosure;

FIGS. 31A-31B are schematic illustrations of an alternative lens removalsystem for a modular IOL according to an embodiment of the presentdisclosure;

FIGS. 31C-31N are schematic illustrations of an alternative lens removalsystem for a modular IOL according to an embodiment of the presentdisclosure;

FIGS. 32A-32D are schematic illustrations of an embodiment of a modularIOL removal system and method; and

FIGS. 33A-33D are schematic illustrations of an embodiment of a modularIOL removal system and method.

DETAILED DESCRIPTION

With reference to FIG. 1, the human eye 10 is shown in cross section.The eye 10 has been described as an organ that reacts to light forseveral purposes. As a conscious sense organ, the eye allows vision. Rodand cone cells in the retina 24 allow conscious light perception andvision including color differentiation and the perception of depth. Inaddition, the human eye's non-image-forming photosensitive ganglioncells in the retina 24 receive light signals which affect adjustment ofthe size of the pupil, regulation and suppression of the hormonemelatonin, and entrainment of the body clock.

The eye 10 is not properly a sphere; rather it is a fused two-pieceunit. The smaller frontal unit, more curved, called the cornea 12 islinked to the larger unit called the sclera 14. The corneal segment 12is typically about 8 mm (0.3 in) in radius. The sclera 14 constitutesthe remaining five-sixths; its radius is typically about 12 mm. Thecornea 12 and sclera 14 are connected by a ring called the limbus. Theiris 16, the color of the eye, and its black center, the pupil, are seeninstead of the cornea 12 due to the cornea's 12 transparency. To seeinside the eye 10, an ophthalmoscope is needed, since light is notreflected out. The fundus (area opposite the pupil), which includes themacula 28, shows the characteristic pale optic disk (papilla), wherevessels entering the eye pass across and optic nerve fibers 18 departthe globe.

Thus, the eye 10 is made up of three coats, enclosing three transparentstructures. The outermost layer is composed of the cornea 12 and sclera14. The middle layer consists of the choroid 20, ciliary body 22, andiris 16. The innermost layer is the retina 24, which gets itscirculation from the vessels of the choroid 20 as well as the retinalvessels, which can be seen within an ophthalmoscope. Within these coatsare the aqueous humor, the vitreous body 26, and the flexible lens 30.The aqueous humor is a clear fluid that is contained in two areas: theanterior chamber between the cornea 12 and the iris 16 and the exposedarea of the lens 30; and the posterior chamber, between the iris 16 andthe lens 30. The lens 30 is suspended to the ciliary body 22 by thesuspensory ciliary ligament 32 (Zonule of Zinn), made up of finetransparent fibers. The vitreous body 26 is a clear jelly that is muchlarger than the aqueous humor.

The crystalline lens 30 is a transparent, biconvex structure in the eyethat, along with the cornea 12, helps to refract light to be focused onthe retina 24. The lens 30, by changing its shape, functions to changethe focal distance of the eye so that it can focus on objects at variousdistances, thus allowing a sharp real image of the object of interest tobe formed on the retina 24. This adjustment of the lens 30 is known asaccommodation, and is similar to the focusing of a photographic cameravia movement of its lenses.

The lens has three main parts: the lens capsule, the lens epithelium,and the lens fibers. The lens capsule forms the outermost layer of thelens and the lens fibers form the bulk of the interior of the lens. Thecells of the lens epithelium, located between the lens capsule and theoutermost layer of lens fibers, are found predominantly on the anteriorside of the lens but extend posteriorly just beyond the equator.

The lens capsule is a smooth, transparent basement membrane thatcompletely surrounds the lens. The capsule is elastic and is composed ofcollagen. It is synthesized by the lens epithelium and its maincomponents are Type IV collagen and sulfated glycosaminoglycans (GAGs).The capsule is very elastic and so causes the lens to assume a moreglobular shape when not under the tension of the zonular fibers, whichconnect the lens capsule to the ciliary body 22. The capsule variesbetween approximately 2-28 micrometers in thickness, being thickest nearthe equator and thinnest near the posterior pole. The lens capsule maybe involved with the higher anterior curvature than posterior of thelens.

Various diseases and disorders of the lens 30 may be treated with anIOL. By way of example, not necessarily limitation, a modular IOLaccording to embodiments of the present disclosure may be used to treatcataracts, large optical errors in myopic (near-sighted), hyperopic(far-sighted), and astigmatic eyes, ectopia lentis, aphakia,pseudophakia, and nuclear sclerosis. However, for purposes ofdescription, the modular IOL embodiments of the present disclosure aredescribed with reference to cataracts.

The following detailed description describes various embodiments of amodular IOL system including primary and secondary intraocularcomponents, namely an intraocular base configured to releasably receivean intraocular lens. In some embodiments, the base may be configured toprovide optical correction, in which case the modular IOL system may bedescribed as including a primary lens and a secondary lens. Theprinciples and features described with reference to embodiments wherethe base is configured for optical correction may be applied toembodiments where the base is not configured for optical correction, andvice versa. Stated more broadly, features described with reference toany one embodiment may be applied to and incorporated into otherembodiments.

With reference to FIGS. 2A and 2B, a modular IOL system 50/60 is shownimplanted in the capsular bag 34 of lens 30 having a capsulorhexis 36formed therein. The modular IOL system may include a primary lens 50 anda secondary lens 60. The primary lens 50 may include a body portion 52,a pair of haptics 54 for anchoring and centering the primary lens 50 inthe capsular bag 34, and means for attachment (not shown here, butdescribed later) to the secondary lens 60. The secondary lens 60 mayinclude an optic body portion 62, no haptics, and corresponding meansfor attachment (not shown here, but described later) to the primary lens50. The anterior surface of the body portion 52 of the primary lens 50may be in intimate contact with the posterior surface of the bodyportion 62 of the secondary lens 60, without any intervening material(e.g., adhesive, aqueous humor, tissue ingrowth, etc.) in between. Forexample, the anterior surface of the body portion 52 may be in directedcontact with the posterior surface of body portion 62. The secondarylens 60 may be acutely and chronically releasably attached to theprimary lens 50 to facilitate exchange of the secondary lens 60 whilethe primary lens 50 remains in the capsular bag 34 of the lens 30.

The body portion 52 of the primary lens 50 may provide some refractivecorrection, but less than required for an optimal optical result. Theoptimal optical result may be provided by the combination of thecorrection provided by the optical body portion 52 of the primary lens50 together with the optical body portion 62 of the secondary lens 60.For example, the optical body portion 62 of the secondary lens 60 maychange (e.g., add or subtract) refractive power (for monofocalcorrection), toric features (for astigmatism correction), and/ordiffractive features (for multifocal correction).

The secondary lens 60 may have an outside diameter d1, the capsulorhexis36 may have an inside diameter d2, and the body 52 of the primary lens50 may have an outside diameter d3, where d1<d2 d3. This arrangementprovides a gap between the secondary lens 60 and the perimeter of thecapsulorhexis 36 such that the secondary lens 60 may be attached ordetached from the primary lens 50 without touching or otherwisedisturbing any portion of the capsular bag 34. By way of example, notlimitation, assuming the capsulorhexis has a diameter of approximately 5to 6 mm, the body of the primary lens (i.e., excluding the haptics) mayhave a diameter of approximately 5 to 8 mm, and the secondary lens mayhave a diameter of approximately 3 to less than 5 mm, thereby providinga radial gap up to approximately 1.5 mm between the secondary lens andthe perimeter of the capsulorhexis. Notwithstanding this example, anysuitable dimensions may be selected to provide a gap between thesecondary lens and the perimeter of the capsulorhexis in order tomitigate the need to manipulate the lens capsule to attach the secondarylens to the primary lens.

With reference to FIGS. 3A-3D (front views) and 4A-4D (sidecross-sectional views), a method for implanting a modular IOL system50/60 is shown schematically. As seen in FIGS. 3A and 4A, a lens 30 withcataracts includes an opaque or clouded center 38 inside a capsular bag34. Access to the lens 30 for cataract surgery may be provided by one ormore lateral incisions in the cornea. For illustrative purposes, theterm corneal incision will be used throughout this text, though itshould be understood that this includes any appropriate incision toprovide access to the lens capsule, including a scleral incision.

A capsulorhexis (circular hole) 36 may be formed in the anteriorcapsular bag 34 using manual tools or a femtosecond laser. As seen inFIGS. 3B and 4B, the opaque center 38 is removed by phacoemulsificationand/or aspiration through the capsulorhexis 36. The primary lens 50 isdelivered in a rolled configuration using a tube inserted through thecapsulorhexis 36 and into the capsular bag 34. The primary lens 50 isejected from the delivery tube and allowed to unfurl. With gentlemanipulation, the haptics 54 of the primary lens engage the insideequator of the lens capsule 34 and center the lens body 52 relative tothe capsulorhexis 36 as seen in FIGS. 3C and 4C. The secondary lens 60is delivered in a rolled configuration using a tube, positioning thedistal tip thereof adjacent the primary lens 50. The secondary lens 60is ejected from the delivery tube and allowed to unfurl. With gentlemanipulation, the secondary lens 60 is centered relative to thecapsulorhexis 36. Without manipulating the capsular bag 34 or theprimary lens 50, the secondary lens 60 is then attached to the primarylens 50 as seen in FIGS. 3D and 4D. If necessary, the secondary lens 60may be removed and/or replaced in a similar manner, reversing the stepswhere appropriate. As an alternative, the primary 50 and secondary 60lenses may be implanted as a unit, thus eliminating a delivery step.

Because it may be difficult to ascertain which side of the secondarylens 60 should face the primary lens 50, the secondary lens may includea marking indicative of proper position. For example, a clockwise arrowmay be placed along the perimeter of the anterior surface of thesecondary lens 60, which appears as a clockwise arrow if positionedright-side-up and a counter-clockwise arrow if positioned wrong-side-up.Alternatively, a two-layered color marking may be placed along theperimeter of the anterior surface of the secondary lens 60, whichappears as a first color if positioned right-side-up and a second colorif positioned wrong-side-down. Other positionally indicative markingsmay be employed on the secondary lens 60, and similar marking schemesmay be applied to the primary lens 50.

With reference to FIG. 5, subsurface attachment mechanisms 70 may beused to releasably secure the secondary lens 60 to the primary lens 50.The attachment mechanisms 70 may be positioned radially inside theperimeter of the capsulorhexis 36 and radially outside the field of viewto avoid interference with light transmission. Alternatively or inaddition, the attachment mechanism 70 may have radial and lateralextents limited to a small fraction (e.g., less than 10-20%) of theperimeter of the secondary lens 50 to minimize the potential forinterference in light transmission. Two diametrically opposed attachmentmechanisms 70 are shown, but any suitable number may be used, uniformlyor non-uniformly distributed about the circumference of the secondarylens 60.

If the primary lens 50 and the secondary lens 60 are delivered at thesame time, it may be desirable to align the attachment mechanisms 70with the roll axis 80, around which the lenses 50 and 60 may be rolledfor insertion via a delivery tool. Because the secondary lens 60 mayshift relative to the primary lens 50 when rolled about axis 80,providing the attachment mechanisms 70 along the roll axis 80 minimizesstress to the attachment mechanisms 70. To this end, the attachmentmechanisms 70 may be coaxially aligned relative to the roll axis 80 andmay be configured to extend a limited distance (e.g., less than 10-20%of the perimeter of the secondary lens 60) from the axis 80.

The attachment mechanisms 70 may be configured to have mating orinterlocking geometries as shown in FIGS. 6A and 6B. Generally, thegeometries include a male portion and female portion that are releasablyconnectable. The female portion is configured to receive the maleportion and limit relative motion between the primary lens 50 and thesecondary lens 60 in at least two dimensions (e.g., superior-inferiorand right-left). The female and male portions may be configured to havean interlocking geometry such that relative motion between the primarylens 50 and the secondary lens 60 is limited in three dimensions (e.g.,superior-inferior, right-left, anterior-posterior). The attachmentmechanisms 70 may be engaged and disengaged by applying orthogonal forcein a posterior (push) and anterior (pull) direction, respectively. Theattachment mechanisms 70 may be pre-formed by molding, cutting, etching,or a combination thereof, for example.

In the examples shown, each attachment mechanism 70 comprises aninterlocking cylindrical protrusion 72 and cylindrical recess or groove74. Other mating or interlocking geometries may be used as well. Thecylindrical geometry shown has the advantage of allowing slight rotationof the secondary lens 60 relative to the primary lens 50 when rolled fordelivery, thus further reducing stress thereon. As shown in FIG. 6A, thecylindrical protrusion 72 may extend anteriorly from the anteriorsurface of the body 52 of the primary lens 50, and the cylindricalrecess 74 may extend anteriorly through the posterior surface of thebody 62 of the secondary lens 60 adjacent a radial peripheral zonethereof. Alternatively, as shown in FIG. 6B, the cylindrical protrusion72 may extend posteriorly from the posterior surface of the body 62 ofthe secondary lens 60 adjacent a radial peripheral zone thereof, and thecylindrical recess 74 may extend posteriorly through the anteriorsurface of the body 52 of the primary lens 50. The configuration shownin FIG. 6B may be particularly suited for the case where the primarylens 50 is a pre-existing implanted IOL into which the recess 74 may beetched in-situ, by laser, for example.

With reference to FIG. 7, extension attachment mechanisms 90 may be usedto releasably connect the primary 50 and secondary 60 lenses. Extensionattachment mechanisms 90 may be similar to subsurface attachmentmechanisms 70 except as shown and described. Extension attachmentmechanisms 90 may extend radially from the perimeter of the secondarylens 60, with each including mating or interlocking geometries, examplesof which are shown in FIGS. 8A-8C. In FIG. 8A, a cylindrical portion 92extends from the outer edge of the secondary lens 60, and a cylindricalrecess 94 extends from the outer edge of the primary lens 50. In FIG.8B, the corollary is shown, with the cylindrical portion 92 extendingfrom the outer edge of the primary lens 50, and the cylindrical recess94 extending from the outer edge of the secondary lens 60. In bothembodiments shown in FIGS. 8A and 8B, the attachment mechanisms 90 maybe engaged and disengaged by applying orthogonal force in a posterior(push) and anterior (pull) direction, respectively. Alternatively, inthe embodiment shown in FIG. 8C, the attachment mechanisms 90 may beengaged and disengaged by applying rotational force in a clockwise orcounterclockwise direction, depending on which lens 50/60 is attached toeach of the cylindrical portion 92 and the cylindrical recess 94. Inaddition, although the embodiment of FIG. 7 only depicts the use of twoattachment mechanisms 90, any suitable number of attachment mechanisms90 may be utilized within the principles of the present disclosure.

With reference to FIGS. 9A-9D, the portion of attachment mechanism 90associated with the secondary lens 60 may be positioned such that thecenter of the secondary lens 60 is aligned with the center of theprimary lens 50. Alternatively, to adjust for misalignment of theprimary lens 50 due to imbalanced post-operative healing, for example,the portion of attachment mechanism 90 associated with the secondarylens 60 may be offset as shown in FIGS. 9B-9D. In FIG. 9B, the portionof attachment mechanism 90 associated with the secondary lens 60 isrotationally offset. In FIG. 9C, the portion of attachment mechanism 90associated with the secondary lens 60 is superiorly offset. In FIG. 9D,the portion of attachment mechanism 90 associated with the secondarylens 60 is laterally offset. An anterior-posterior offset may also beemployed as described in more detail with reference to FIGS. 11C and11F. Each of the embodiments shown in FIGS. 9B, 9C, 9D, 11C and 11F areprovided by way of example, and the offset may be made in any direction(anterior, posterior, superior, inferior, right, left, clockwise,counterclockwise) or combination thereof, to varying magnitudesdepending on the misalignment of the primary lens 50. In addition,attachment mechanism 90 is shown by way of example, but the sameprinciples may be applied to other attachment means described herein.

With reference to FIG. 10, alternative subsurface attachment mechanisms100 may be used to releasably connect the secondary lens 50 to theprimary lens 60. Subsurface attachment mechanisms 100 may be similar tosubsurface attachment mechanisms 70 except as shown and described.Subsurface attachment mechanisms 100 may comprise mating or interlockinggeometries extending along an arcuate path adjacent the peripheral edgeof the secondary lens 60. The subsurface attachment mechanism 100 mayinclude a protrusion 102 and a corresponding recess or groove 104 intowhich the protrusion 102 may be received. The protrusion 102 may extendfrom the posterior surface of the secondary lens 60 and thecorresponding recess or groove 104 may extend into the anterior surfaceof the primary lens 50 as shown in FIGS. 11A (separated) and 11D(attached). Alternatively, the protrusion 102 may extend from theanterior surface of the primary lens 50 and the corresponding the recessor groove 104 may extend into the posterior surface of the secondarylens 60 as shown in FIGS. 11B (separated) and 11E (attached). In eitherembodiment, the anterior-posterior dimension of the protrusion 102 maymatch the same dimension of the recess or groove 104 to provide intimatecontact between the anterior surface of the primary lens 50 and theposterior surface of the secondary lens 60. Alternatively, theanterior-posterior dimension of the protrusion 102 may exceed the samedimension of the recess or groove 104 to provide an anterior-posterioroffset as shown in FIGS. 11C (separated) and 11F (attached). Further,those of ordinary skill in the art will readily recognize that anysuitable number of attachment mechanisms 100 may be utilized within theprinciples of the present disclosure.

With reference to FIG. 12A, alternative subsurface attachment mechanisms105 may be used to connect the secondary lens 60 to the primary lens 50.Subsurface attachment mechanisms 105 may be similar to subsurfaceattachment mechanisms 100 except as shown and described. As seen in FIG.12B, which is a cross-sectional view taken along line B-B in FIG. 12A,the subsurface attachment mechanism 105 may comprise mating orinterlocking geometries including a protrusion 107 and a series of holes109 into which the protrusion 107 may be received. The holes 109 may bedistributed in a pattern as seen in FIG. 12C, which shows severalalternative detail views of box C in FIG. 12A. In FIG. 12C, theprotrusion 107 resides in a hole 109 designated as a black circle whilethe remaining holes 109 designated as white circles remain open. Withthis arrangement, the protrusions 107 may be placed in a correspondingpair of holes 109 to achieve the desired alignment between the primary50 and secondary 60 lenses. For example, and with continued reference toFIG. 12C, the protrusions 107 may be placed in a corresponding pair ofholes 109 to achieve centered (nominal), shift right, shift left, shiftup, shift down, rotate clockwise or rotate counterclockwise (labeledC1-C7, respectively) alignment between the primary 50 and secondary 60lenses. This arrangement provides a range of adjustments as describedwith reference to FIGS. 9A-9D. In addition, any suitable number ofattachment mechanisms 105 may be disposed uniformly or non-uniformlyabout a perimeter of lenses 50 and 60.

All or a portion of the various subsurface attachment means describedherein may be formed by molding, cutting, milling, etching or acombination thereof. For example, with particular reference to FIG. 11A,the groove 104 may be formed by in-situ laser etching a pre-existingimplanted primary lens 50, and the protrusion may be pre-formed bymolding, milling or cutting the secondary lens 60.

Examples of lasers that may be used for in-situ etching includefemtosecond lasers, ti/saph lasers, diode lasers, YAG lasers, argonlasers and other lasers in the visible, infrared and ultraviolet range.Such lasers may be controlled in terms of energy output, spatial controland temporal control to achieve the desired etch geometry and pattern.In-situ etching may be accomplished, for example, by transmitting alaser beam from an external laser source, through the cornea and pastthe pupil. Alternatively, in-situ etching may be accomplished bytransmitting a laser beam from a flexible fiber optic probe insertedinto the eye.

With reference to FIGS. 13A and 13B, photomicrographs at 4× and 40×magnification, respectively, show how a groove (see, arrow) wasexperimentally etched in a primary lens by laser etching. A femtosecondlaser set within the following ranges may be used to etch the groove:power of 1 nJ to 100 uJ; pulse duration of 20 fs up to the picosecondrange; and a frequency of 1 to 250 kHz.

The primary and secondary components of the modular IOL systemsdisclosed herein may be formed of the same, similar or dissimilarmaterials. Suitable materials may include, for example, acrylate-basedmaterials, silicone materials, hydrophobic polymers or hydrophilicpolymers, and such materials may have shape-memory characteristics. Forexample, materials comprising the optical portions of the modular lenssystem can be silicone, PMMA, hydrogels, hydrophobic acrylic,hydrophilic acrylic or other transparent materials commonly used forintraocular lenses. Non-optical components of the modular IOL mightinclude nitinol, polyethylene sulfone and/or polyimide.

Materials can be selected to aid performance of certain features of themodular lens system notably the attachment and detachment featuresnecessary for the primary and secondary lenses as previously described.Other features of the modular lens that can be enhanced with specificmaterial selections include manufacturability, intraoperative andpost-operative handling, fixation (both intraoperative and at time ofpost-operative modification), reaching micro-incision sizes (<2.4 mm)and exchangeability (minimal trauma on explantation of lenses).

For example, in one embodiment the primary lens and the secondary lensare made from hydrophobic acrylic material having a glass transitiontemperature between approximately 5 and 300 C and a refractive indexbetween approximately 1.41-1.60. In another embodiment, the primary andsecondary lens can be made from different materials having differentglass transition temperatures and mechanical properties to aid fixationand detachment properties of the modular system. In another embodiment,both or either of the modular lens system is made from materialsallowing for compression to an outer diameter equal to or smaller thanapproximately 2.4 mm.

Material properties that are generally desirable in the modular IOLsystem include minimal to no glistening formation, minimal pitting whenexposed to YAG laser application and passing standard MEM elutiontesting and other biocompatibility testing as per industry standards.The material may contain various chromophores that will enhance UVblocking capabilities of the base material. Generally, wavelengths thatare sub 400 nm are blocked with standard chromophores at concentrations≤1%. Alternatively or in addition, the material may contain blue lightblocking chromophores, e.g., yellow dyes which block the desired regionof the blue-light spectrum. Suitable materials are generally resistantto damage, e.g., surface abrasion, cracking, or hazing, incurred bymechanical trauma under standard implantation techniques.

The components of the modular IOL may be formed by conventionaltechniques such as molding, cutting, milling, etching or a combinationthereof.

As an alternative to mechanical attachment, chemical attraction betweenthe primary and secondary components may be utilized. Using similarmaterials with a smooth surface finish may facilitate chemicalattraction. Chemical attraction may be enhanced by surface activationtechniques such as plasma or chemical activation. In some instances, itmay be desirable to reduce chemical attraction to avoid sticking betweenthe materials and rely more on mechanical attachment for stability. Inthis case, the primary and secondary components may be formed ofdissimilar materials or otherwise have adjacent surfaces that do nothave a chemical attraction.

With reference to FIGS. 14-14C, an alternative modular IOL 140 is shownin front, sectional and detailed views, respectively. FIG. 14A shows across-sectional view taken along line A-A in FIG. 14, FIG. 14B shows across sectional view taken along line B-B in FIG. 14, and FIG. 14C showsa detail view of circle C in FIG. 14B. Modular IOL 140 may include aprimary lens 50 with haptics 54 and a secondary lens 60. The interfacingsurfaces of the primary lens 50 (anterior surface) and secondary lens 60(posterior surface) may be in intimate contact as best seen in FIGS. 14Aand 14B. Maintaining intimate contact (i.e., avoiding a gap) ormaintaining a consistent gap between the interfacing surfaces of theprimary lens 50 and the secondary lens 60 may reduce the likelihood ofinduced astigmatism. In some embodiments, however, a substance (e.g., anadhesive agent) may be disposed between the respective surfaces oflenses 50 and 60. A circular extension may be formed in the secondarylens 60, with a correspondingly sized and shaped circular recess formedin the primary lens 50 to form an interference fit therebetween, thussecurely connecting the two components. The depth of the recess in theprimary lens 50 may be a fraction of the thickness of the secondary lens60, with a circular extension of the secondary lens 60 extending over aportion of the primary lens 50, thereby forming an overlap joint 142 asbest seen in FIG. 14C. The overlap joint 142 may extend 360 degreesaround the circumference of the secondary lens 60 as shown, or afraction thereof. The circular extension of the secondary lens 60 risesabove the anterior surface of the primary lens 50 to form a raisedportion. In some embodiments, the raised portion may have a radiallytapering configuration. The raised portion may be radially compressedwith forceps to facilitate connection and disconnection of the primarylens 50 and the secondary lens 60. Using radial compression to insertthe secondary lens 60 into the primary lens 50 reduces theanterior-posterior forces applied to the capsular bag during insertion,thereby reducing the risk of capsular rupture.

With reference to FIGS. 15-15D, an alternative modular IOL 150 is shownin front, sectional and detailed views, respectively. FIG. 15A shows across-sectional view taken along line A-A in FIG. 15, FIG. 15B shows across sectional view taken along line B-B in FIG. 15, FIG. 15C shows adetail view of circle C in FIG. 15B, and FIG. 15D shows an alternativedetail view of circle C in FIG. 15B. Modular IOL 150 may include aprimary lens 50 with haptics 54 and a secondary lens 60. The interfacingsurfaces of the primary lens 50 (anterior surface) and secondary lens 60(posterior surface) may be in intimate contact as best seen in FIGS. 15Aand 15B. The primary lens 50 may include a recess defining a wall intowhich the correspondingly sized and shaped circular secondary lens 60may be placed. The wall defined by the recess in the primary lens 50 mayextend around the entire perimeter of the primary lens with theexception of two diametrically opposed gaps 152. The gaps 152 thusexpose the perimeter edge of the secondary lens 60 as seen in FIG. 15Ato facilitate insertion and removal by radial compression of thesecondary lens 60 using forceps, for example. The remainder of the walldefined by the recess in the primary lens provides for a flush joint asseen in FIGS. 15B and 15C, where the anterior surface of the secondarylens 60 may be flush with the anterior surface of the primary lens 50.As seen in FIG. 15C, the wall defined by the recess in the primary lens50 and the interfacing edge of the secondary lens 60 may be cantedinwardly to provide a joint 154 with positive mechanical capture andsecure connection therebetween. Alternatively, as seen in FIG. 15D, thewall defined by the recess in the primary lens 50 and the interfacingedge of the secondary lens 60 may be “S” shaped to provide a joint 156with positive mechanical capture and secure connection therebetween.Alternative interlocking geometries may be employed.

With reference to FIGS. 16-16D, an alternative modular IOL 160 is shownin front, sectional and detailed views, respectively. FIG. 16A shows across-sectional view taken along line A-A in FIG. 16, FIG. 16B shows across sectional view taken along line B-B in FIG. 16, FIG. 16C shows adetail view of circle C in FIG. 16B, and FIG. 16D shows a detail view ofcircle D in FIG. 16A. Modular IOL 160 may be configured similar tomodular IOL 150 shown in FIGS. 15-15D with primary lens 50 including arecess defining a wall into which the correspondingly sized and shapedcircular secondary lens 60 may be placed. However, in this embodiment,an angular gap 162 (rather than gap 152) is provided along a fraction ofthe perimeter of the secondary lens 60. The wall defined by acircumferential portion of the perimeter edge of the secondary lens 60may have the same geometry as the wall defined by the recess in theprimary lens 50 to provide a flush joint 154 as best seen in FIG. 16C.The wall defined by another (e.g., the remainder) circumferentialportion of the perimeter edge of the secondary lens 60 may have a moreinwardly angled geometry to provide an angled gap 162 as best seen inFIG. 16D. The angled gap 162 thus exposes the perimeter edge of thesecondary lens 60 as seen in FIG. 16D into which forceps may be placedto facilitate insertion and removal by radial compression of thesecondary lens 60. Alternative gap geometries may be employed.

With reference to FIGS. 17-17C, an alternative modular IOL 170 is shownin front, sectional, detailed and isometric views, respectively. FIG.17A shows a cross-sectional view taken along line A-A in FIG. 17, FIG.17B shows a detail view of circle B in FIG. 17A, and FIG. 17C shows anisometric view of the assembled components. Modular IOL 170 may beconfigured similar to modular IOL 150 shown in FIGS. 15-15D with primarylens 50 including a recess defining a wall into which thecorrespondingly sized and shaped circular secondary lens 60 may beplaced. However, in this embodiment, the wall defining the recess in theprimary lens 50 includes a portion thereof that is milled down to definetwo diametrically opposed tabs 172. The inside circumferential walls ofthe tabs 172 provide for a flush joint 174 as seen in FIG. 17B, suchthat the anterior surface of the secondary lens 60 is flush with theanterior surface of the primary lens 50. The interface of the joint 174along the tabs 172 may be canted, “S” shaped, or “C” shaped as shown,for example. Elsewhere along the perimeter, away from the tabs 172, inthe area where the wall is milled down, the perimeter edge of thesecondary lens 60 is exposed as seen in FIG. 17C, to facilitateinsertion and removal of the secondary lens 60 by radial compressionthereof using forceps, for example.

With reference to FIGS. 18-18C, an alternative modular IOL 180 is shownin front, sectional, detailed and isometric views, respectively. FIG.18A shows a cross-sectional view taken along line A-A in FIG. 18, FIG.18B shows a detail view of circle B in FIG. 18A, and FIG. 18C shows anisometric view of the assembled components. Modular IOL 180 may beconfigured similar to modular IOL 170 shown in FIGS. 17-17C with primarylens 50 including a recess defining a partial wall into which thecorrespondingly sized and shaped circular secondary lens 60 may beplaced, interlocking via flush joint 174 in tabs 172. However, in thisembodiment, grasping recesses or holes 182 are provided in each of thetabs 172 and in the adjacent portions of secondary lens 60. In oneembodiment, the grasping recesses or holes 182 may not extend through anentire thickness of primary 50 and secondary 60 lenses. The graspingholes 182 in the secondary lens 60 facilitate insertion and removal byradial compression of the secondary lens 60 using forceps, for example.Adjacent grasping holes 182 in the tab portion 172 and the secondarylens 60 may be pulled together or pushed apart in a radial direction tofacilitate connection and disconnection, respectively, of the joint 174using forceps, for example.

Using radial forces applied via the grasping holes 182 to connect anddisconnect (or lock and unlock) the joint 174 between the primary lens50 and the secondary lens 60 reduces the anterior-posterior forcesapplied to the capsular bag, thereby reducing the risk of capsularrupture. Grasping holes 182 may also be used to facilitate connectingand disconnecting different interlocking geometries while minimizinganterior-posterior forces. For example, a recess in the primary lens 50may include internal threads that engage corresponding external threadson the perimeter edge of the secondary lens 60. In this embodiment,forceps inserted into the grasping holes 182 may be used to facilitaterotation of the secondary lens 60 relative to the primary lens 50 toscrew and unscrew the primary 50 and secondary 60 lenses. In analternative embodiment, a keyed extension of the secondary lens 60 maybe inserted into an keyed opening in the primary lens 50 and rotatedusing forceps inserted into the grasping holes 182 to lock and unlockthe primary 50 and secondary 60 lenses. In another alternativeembodiment, forceps or the like may be inserted posteriorly through ahole in the secondary lens 60 to grasp an anterior protrusion on theprimary lens 50 like a handle (not shown), followed by applyingposterior pressure to the secondary lens 60 while holding the primarylens 50 stationary. The grasping holes 182 may also be used to rotatethe secondary lens 60 relative to the primary lens 50 for purposes ofrotational adjustment in toric applications, for example.

With reference to FIGS. 19-19D, an alternative modular IOL 190 is shownin front, sectional, detailed, isometric exploded and isometricassembled views, respectively. FIG. 19A shows a cross-sectional viewtaken along line A-A in FIG. 19, FIG. 19B shows a detail view of circleB in FIG. 19A, FIG. 19C shows an exploded isometric view of thecomponents, and FIG. 19D shows an assembled isometric view of thecomponents. Modular IOL 190 differs from some of the previouslydescribed embodiments in that the primary component serves as a base 55but does not necessarily provide for optical correction, whereas thesecondary component serves as a lens 65 and provides for opticalcorrection. Base 55 may be configured in the shape of an annulus or ringwith a center opening 57 extending therethrough in an anterior-posteriordirection. In some embodiments, base 55 may not define a complete ringor annulus. Base 55 may also include haptics 59, which are similar infunction to haptics 54 described previously but differ in geometricconfiguration. Generally, haptics 54/59 function to center the base 55in the capsular bag. Such haptics may also be configured to applyoutward tension against the inside equatorial surface of the capsularbag, similar to capsular tension rings, to aid in symmetric healing andmaintain centration of the base. The haptics 59 may include one or moreopenings therein.

Because the base 55 includes a center opening 57, the posterior opticalsurface of the lens 65 is not in contact with the base 55. A circularextension may be formed in the lens 65, with a correspondingly sized andshaped circular recess formed in the base 55 to form a ledge on the base55 and an overlapping joint 192 with an interference and/or friction fittherebetween, thus securely connecting the two components.Alternatively, the shape of the overlapping joint 192 may form a cantedangle or an “S” shape as described previously to form an interlocktherebetween. The joint or junction 192 may include a modified surfaceto reduce light scattering caused by the junction 192. For example, oneor both of the interfacing surfaces of the joint 192 may be partially tototally opaque or frosted (i.e., roughened surface) to reduce lightscattering caused by the junction 192.

The depth of the recess in the base 55 may be the same thickness of thecircular extension of the lens 65 such that the anterior surface of thelens 65 and the anterior surface of the base 55 are flush as best seenin FIG. 19B. With this arrangement, the posterior surface of the lens 65extends more posteriorly than the anterior surface of the base 55. Insome embodiments, however, the anterior surface of lens 65 may bedisposed relatively higher or lower than the anterior surface of base55. The dimensions of the recess and the corresponding ledge in the base55 may be selected relative to the thickness of the lens 65 such that atleast a portion of the posterior-most surface of the lens 65 is coplanarwith the posterior-most surface of the base 55, or such that at least aportion of the posterior-most surface of the lens 65 is more posteriorthan the posterior-most surface of the base 55.

As with prior embodiments, the lens may be exchanged for a differentlens either intra-operatively or post-operatively. This may bedesirable, for example, if the first lens does not provide for thedesired refractive correction, in which case the first lens may beexchanged for a second lens with a different refractive correction,without disturbing the lens capsule. In cases where the lens 65 does nothave the desired optical alignment due to movement or misalignment ofthe base, for example, it may be exchanged for a different lens with anoptical portion that is manufactured such that it is offset relative tothe base 55. For example, the optical portion of the second lens may beoffset in a rotational, lateral and/or axial direction, similar to theembodiments described with reference to FIGS. 9A-9D. This generalconcept may be applied to other embodiments herein where the secondarycomponent (e.g., lens) has limited positional adjustability relative tothe primary component (e.g., base).

A number of advantages are associated with the general configuration ofthis embodiment, some of which are mentioned hereinafter. For example,because the posterior optical surface of the lens 65 is not in contactwith the base 55, the potential for debris entrapment therebetween iseliminated. Also, by way of example, because the base 55 includes acenter opening 57 that is devoid of material, the base 55 may be rolledinto a smaller diameter than a primary lens 50 as described previouslyto facilitate delivery through a smaller incision in the cornea.Alternatively, the base 55 may have a larger outside diameter and berolled into a similar diameter as primary lens 50. For example, the baselens 55 may have an outside diameter (excluding haptics) ofapproximately 8 mm and be rolled into the same diameter as a primarylens 50 with an outside diameter 6 mm. This may allow at least a portionof the junction between the base 55 and lens 65 to be moved radiallyoutward away from the circumferential perimeter of the capsulorhexis,which typically has a diameter of 5-6 mm. Moving at least a portion ofthe junction between the base 55 and the lens 65 radially outward fromthe perimeter of the capsulorhexis may reduce the amount of the junctionthat is in the field of view and thus reduce the potential for lightscattering or optical aberrations (e.g., dysphotopsias) created thereby.Of course, notwithstanding this example, any suitable dimensions may beselected to provide a gap between the lens 65 and the perimeter edge ofthe capsulorhexis in order to mitigate the need to manipulate the lenscapsule to connect or disconnect the lens 65 to or from the base 55.

With reference to FIGS. 20-20D, an alternative modular IOL 200 is shownin front, sectional, detailed, isometric exploded and isometricassembled views, respectively. FIG. 20A shows a cross-sectional viewtaken along line A-A in FIG. 20, FIG. 20B shows a detail view of circleB in FIG. 20A, FIG. 20C shows an exploded isometric view of thecomponents, and FIG. 20D shows an assembled isometric view of thecomponents. Modular IOL 200 includes a base 55 with associated haptics59 and a lens 65. The base 55 includes a center hole 57 such that theposterior optical surface of the lens 65 is not in contact with the base55. The lens 65 includes a circular extension that is sized and shapedto fit in a circular recess formed in the base 55 to form a ledge on thebase 55 and an overlapping joint 202. The overlapping joint 202 may beconfigured with an “S” shaped interface to securely connect the twocomponents. Thus, modular IOL 200 is similar to modular IOL 190, exceptthat the joint 202 between the base 55 and the lens 65 may include apeg-and-hole arrangement. In this arrangement, a pair of diametricallyopposed pegs 204 may extend posteriorly from the posterior perimeter ofthe lens 65 and fit within a selected pair of holes 206 from a series ofholes 206 formed in the ledge of the joint 202 in the base 55.

FIGS. 20E-20I show additional detail of modular IOL 200. FIG. 20E showsa side view of the lens 65, FIG. 20F shows a rear view of the posteriorsurface of the lens 65, FIG. 20G is a detailed view of circle G in FIG.20E, FIG. 20H is a front view of the anterior surface of the base 55,and FIG. 20I is a detailed view of circle I in FIG. 20H. As seen inFIGS. 20E-20F, a pair of diametrically opposed pegs 204 may extendposteriorly from the posterior perimeter of the lens 65. As seen inFIGS. 20H-20I, the inside diameter of the base 55 along the ledge of thejoint 202 includes a series of holes 206, into a selected pair of whichthe pair of pegs 204 may be inserted. With this arrangement, the lens 65may be selectively rotated relative to the base 55 for purposes ofrotational adjustment in toric applications, for example.

With reference to FIGS. 21-21E, an alternative modular IOL 210 is shownin front, sectional, detailed and isometric views, respectively. FIGS.21A and 21B show a cross-sectional views taken along line A-A and lineB-B, respectively, in FIG. 21. FIGS. 21C and 21D show detail views ofcircle C in FIG. 21A and circle D in FIG. 21B, respectively. FIG. 21Eshows an isometric view of the assembled components of the modular IOL210. Modular IOL 210 may be configured similar to a combination ofmodular IOL 190 shown in FIGS. 19-19D and modular IOL 170 shown in FIGS.17-17C. Like modular IOL 190, modular IOL 210 includes a base 55configured in the shape of an annulus or ring with a center opening anda recess defining a wall into which the correspondingly sized and shapedcircular lens 65 may be placed. Like modular IOL 170, the wall definingthe recess extends along the inside perimeter of the base 55, with aportion thereof milled down to define two diametrically opposed tabs212. The inside circumferential walls of the tabs 212 provide for aflush joint 214 as seen in FIG. 21C, such that the anterior surface ofthe lens 65 is flush with the anterior surface of the base 55. Theinterface of the joint 214 along the tabs 212 may be canted, “S” shaped,or “C” shaped as shown, for example. Elsewhere along the perimeter, awayfrom the tabs 212, in the area where the wall is milled down, theperimeter edge of the lens 65 is exposed as seen in FIG. 21D, tofacilitate insertion and removal of the lens 65 by radial compressionusing forceps, for example.

With reference to FIGS. 22-22D, an alternative modular IOL 220 is shownin front, sectional, and detailed views, respectively. FIG. 22A shows across-sectional view taken along line A-A in FIG. 22, FIG. 22B across-sectional view taken along line B-B in FIG. 22, FIG. 22C shows adetail view of circle C in FIG. 22A, and FIG. 22D shows a detail view ofcircle D in FIG. 22B. Modular IOL 220 includes a base 55 with associatedhaptics 59 and a lens 65. The base 55 includes a center hole such thatthe posterior optical surface of the lens 65 is not in contact with thebase 55. The perimeter of the lens 65 is sized and shaped to fit in acircular recess formed in the base 55 to form a ledge on the base 55 anda flush joint 222. The flush joint 222 may be configured with an “S”shaped interface to securely connect the two components. A pair of pegs224 extend anteriorly from the base 55 adjacent the inside perimeterthereof, and through a pair of arc-shaped slots 226 adjacent theperimeter of the lens 65. The arc-shaped slots may extend along afraction of the circumference of the lens 65 as shown in FIG. 22. Withthis arrangement, the lens 65 may be selectively rotated relative to thebase 55 for purposes of rotational adjustment in toric applications, forexample.

The pegs 224 may be sized and configured to rise above the anteriorsurface of the lens 65 as shown in FIG. 22C. Forceps or the like may beinserted posteriorly through the arc-shaped slots 226 in the lens 65 tograsp the pegs 224 like a handle, followed by applying posteriorpressure to the lens 65 while holding the pegs 224 stationary. Byholding the pegs 224 and thus stabilizing the base 55 during connectionof the lens 65 to the base 55, anterior-posterior forces applied to thecapsular bag are reduced, thereby reducing the risk of capsular rupture.

As described herein, lens removal systems and methods for a lens 60/65of a modular IOL are shown in the drawings by way of example and shouldbe understood to embody other modular IOL embodiments. Lens 60/65 mayhave dimensions as shown in the drawings by way of example, notnecessarily limitation.

With reference FIGS. 23A-23D, a lens removal system for a modular IOLaccording to an embodiment of the present disclosure is shownschematically. FIGS. 23A and 23B are side and top views, respectively,of the lens removal system. FIGS. 23C and 23D are top views showing howthe lens removal system may be used to remove lens 60/65. The lensremoval or extractor system may include a cannula 230 and a pair offorceps 235. The cannula 230 may include a lumen sized to slidablyreceive the forceps 235. The cannula 230 may include a tubular shaftportion 232 and a contoured distal opening 234. The cannula 230 may beformed and configured similar to conventional IOL insertion devices, forexample. The forceps 235 include a pair of atraumatic grasping tips 237and a tubular shaft 239. The tubular shaft 239 may be advanced tocompress the tips 237 and grasp the lens 60/65. The forceps 235 may beformed and configured similar to conventional ophthalmology forceps, forexample, except that the tips 237 may be formed of or covered by arelatively soft polymeric material to avoid damage to the lens 60/65.Generally, any devices used to manipulate the modular IOL componentsdescribed herein may be formed of or covered by a relatively softpolymeric material to avoid damage to the components thereof.

With reference to FIGS. 23C and 23D, the cannula 230 may be insertedthrough a corneal incision until its distal end is adjacent thecapsulorhexis. The forceps 235 may be inserted into and through thecannula 230, until the distal tips 237 extend distally beyond the distalend of the cannula 230. The lens 60/65 to be extracted may be graspedwith the forceps 235 as shown in FIG. 23C. With the lens 60/65 securelyheld by the forceps 235, the forceps 235 may be retracted proximallyinto the cannula 230. As the forceps 235 are retracted into the cannula230, the lens 60/65 enters the contoured opening 234. The contouredopening 234 encourages the edges of the lens 60/65 to roll and fold asseen in FIG. 23D. Complete retraction of the forceps 235 into thecannula 230 thus captures the lens 60/65 safely in the lumen of thecannula 230 after which it may be removed from the eye. A similarapproach may also be used to insert the lens 60/65, reversing therelevant steps.

In a related embodiment, surgical instruments may cut the lens 60/65 viaa “peeling” mechanism. FIGS. 23E-23F show a lens removal system that maybe used to remove a lens 60/65. The lens removal system may include alens 60/65 of a modular IOL 290, a cannula 230, forceps 235, and a blade650. The cannula 230 may be substantially similar to the cannula 230described above and configured for insertion through a corneal incision13, for example having an outer diameter less than 2.2 mm. The cannula230 may have an oval or rectangular cross-section to facilitateextraction of lens 60/65 while minimizing the size of the cornealincision. Cut path 610 is shown on the lens 60/65 of modular IOL 290.Cut path 610 may extend from the fixed tab 295, into the optic portion297, and spiraling inward without reaching actuatable tab 296.

FIG. 23G is a detailed view of the blade 650. The blade 650 may be asingle sharp cutting surface of the cannula 230 (as shown) or a separateunit (not shown). As shown, forceps 235 extend distally from the cannula230 in an open configuration.

In use, a lens 60/65 may be extracted from the capsular bag 34 and intothe anterior chamber 15 using methods described herein. The cannula 230may be inserted through a corneal incision 13 and into an anteriorchamber 15 of an eye 10. The forceps 235 may be inserted into andthrough the cannula 230, until the distal tips 237 extend distallybeyond the distal end of the cannula 230. Forceps 235 may securely graspthe lens 60/65. With the lens 60/65 securely held by the forceps 235,the forceps 235 may retract proximally into the cannula 230. As theforceps 235 are retracted into the cannula 230, the lens 60/65 may passthe blade 650, simultaneously slicing the lens 60/65 along the cut path610. The lens 60/65 may rotate as it is cut by blade 650 and pulled intothe lumen of the cannula 230. Retraction of the forceps 235 into thecannula 230 thus captures the lens 60/65 safely in the lumen of thecannula 230 after which it may be removed from the eye by pulling thecannula 230 out of the corneal incision 13. Since the cannula 230 has amaximum width less than the corneal incision 13, the cut lens 60/65 alsohas a maximum width less than the corneal incision 13. This lensextraction system and method may avoid harmful forces on the eye 10, forexample harmful forces in the anterior-posterior direction that maydamage the eye 10 and/or cause posterior rupture.

FIG. 23H shows an alternative embodiment of a lens removal system thatmay be used to remove a lens 60/65. The lens removal system may includea lens 60/65 of a modular IOL 290, a cannula 230, blade 650, and curvedgrasper 240 having a curved upper arm 242 and a curved lower arm (notshown). The cannula 230 may be substantially similar to the cannula 230described above and configured for insertion through a corneal incision13, for example having an outer diameter less than 2.2 mm. Cut path 610is shown on the lens 60/65. Cut path 610 may extend from the fixed tab295, into the optic portion 297, and spiraling inward without reachingactuatable tab 296.

The upper surface of the upper curved arm 242 and the lower surface ofthe lower curved arm (not shown) may both be generally smooth. The lowersurface of the upper curved arm 242 and the upper surface of the lowercurved arm (not shown) may both have surfaces configured to facilitategrasping, for example serrated surfaces. The serrated surfaces may havea plurality of teeth 246. The angle of teeth 246 may be configured witha proximal bias to further facilitate grasping the lens 60/65 during thecutting step and/or retraction.

The curved grasper 240 may be extendable and retractable relative to thecannula 230 and blade 650. In a retracted configuration, the curvedgrasper 240 may fit within the lumen of cannula 230. Upon extension fromthe cannula 230, the curved grasper 240 may curve and form a “hook”configuration, as shown in FIG. 23H. Additionally, the upper curved arm242 and lower curved arm may have a bias for an open configuration suchthat when the curved grasper 240 extends from the cannula 230, thecurved arms separate into the open configuration while curving into the“hook” configuration. Accordingly, as the curved grasper 240 retractsinto the cannula 230, the upper curved arm 242 and lower curved armreturn to a closed or grasping configuration. The curved grasper 240 maybe made of any suitable material to create this biased configuration ofthe curved grasper 240 when it is outside the cannula 230, for example,shape-memory polymers, non-shape-memory polymers, metals, alloys,stainless steel, heat-set nitinol, elastic materials, or super-elasticmaterials.

In use, this embodiment of a lens removal system functions similar toother disclosed embodiments. During grasping, the curved grasper 240 mayextend distally from the cannula 230. Due to the bias of the curvedgrasper 240, upon extension, it forms a curved “hook” configuration andan open configuration. The upper curved arm 242 and lower curved arm(not shown) may encompass the lens 60/65. The curved grasper 240 may bepositioned to facilitate cutting along cut path 610. To initiategrasping, the cannula 230 may extend forward slightly or the curvedgrasper 240 may retract slightly such that the proximal teeth 246 beginto close around the lens 60/65 and the blade 650 approaches the lens60/65. The curved grasper 240 may retract further such that the lens60/65 is pulled into the blade 650, simultaneously slicing the lens60/65 along the cut path 610.

As the curved grasper 240 retracts into the cannula 230, the teeth 246are brought into contact with the lens 60/65. This may distribute thegrasping forces along the length of the curved grasper 240. This mayincrease grip and prevent lens puncture and tearing. During the cut, theportion of lens 60/65 being cut at any given moment will be alwaysadjacent to a portion of the lens 60/65 held by grasper 240. Graspingthe lens 60/65 adjacent to the cut can provide a more stable cut,preventing the lens 60/65 from tearing, flexing, bowing, or crimping.

The lens 60/65 may rotate as it is cut by blade 650 and pulled into thelumen of the cannula 230. This embodiment permits the entire lens 60/65to be retracted into the cannula 230 in one cutting step. Retraction ofthe grasper 240 into the cannula 230 thus captures the lens 60/65 safelyin the lumen of the cannula 230 after which it may be removed from theeye by pulling the cannula 230 out of the corneal incision 13 usingdisclosed methods.

FIGS. 24-26 describe example methods of using modular IOLs according toembodiments of the present disclosure. Although described with referenceto a primary lens and a secondary lens by way of example, notnecessarily limitation, the same or similar methods may be applied othermodular IOL embodiments, including modular IOL embodiments describedherein that comprise a base and a lens.

With reference to FIG. 24, a method for using a modular IOL according toan embodiment of the present disclosure is shown in a schematic flowchart. In this example, the secondary lens may be exchanged in the eventof a sub-optimal optical result detected intra-operatively. An IOLimplant procedure, such as cataract surgery, may be started 110according to conventional practice. The native lens may then be prepared112 to receive a modular IOL using conventional steps such as makingcorneal access incisions, cutting the capsulorhexis in the anteriorcapsular bag and removing the cataract lens by phacoemulsification. Thebase lens (i.e., primary lens 50) is then placed 114 in the lenscapsule. The secondary lens (i.e., secondary lens 60) is then placed 116on the base lens within the perimeter of the capsulorhexis withouttouching or otherwise disturbing the capsular bag. The attachment meansis then engaged 118 to releasably connect the secondary lens to the baselens. Alternatively, the secondary lens may be attached to the base lensbefore placement in the lens capsule, such that the base lens and thesecondary lens are inserted together as a unit. With both the base lensand the secondary lens in place, the optical result may be measured 120,for example by intra-operative aberrometry. The optical result may takeinto consideration refractive correction, centricity, toric correction,etc. A decision 122 is then made as to whether the optical result isoptimal or sub-optimal. If the optical result is optimal or otherwiseadequate, the IOL procedure is completed 124. However, if the opticalresult is sub-optimal, inadequate and/or the patient is otherwisedissatisfied, the attachment means may be disengaged 126 and thesecondary lens may be removed 128. A different secondary lens may bethen placed 116 on the base lens, following the same subsequent steps asshown. The different secondary lens may have, for example, a differentrefractive power to correct refractive error, a different offset tocorrect for decentration, or a different toric power to correct fortoric error.

With reference to FIG. 25, an alternative method for using a modular IOLaccording to an embodiment of the present disclosure is shown in aschematic flow chart. In this example, the secondary lens may beexchanged in the event of a sub-optimal optical result detectedpost-operatively. The same steps 110-118, and 124 may be performed asdescribed previously, except that the patient is allowed to acclimate130 to the modular IOL for a period of 1-4 weeks or more, for example.Upon a return visit, the optical result is measured 120 and adetermination 122 is made as to whether the optical result is optimal orsub-optimal. If the optical result is optimal or otherwise adequate, theprocedure is stopped 132. If the optical result is sub-optimal,inadequate and/or the patient is otherwise dissatisfied, a revisionprocedure may be initiated 134 to replace the secondary lens followingsteps 126, 128, 116 and 118 as described previously.

This method allows the lens capsule to heal before deciding whether theoptical result is sufficient, which may be advantageous to the extentthe healing process alters the position of the primary and/or secondarylens. This method may also be applied on a chronic basis, where theoptical needs or desires of the patient change over the course of alonger period of time (e.g., >1 year). In this example, the patient mayrequire or desire a different correction such as a stronger refractivecorrection, a toric correction, or a multifocal correction, each ofwhich may be addressed with a different secondary lens.

With reference to FIG. 26, another alternative method for using amodular IOL according to an embodiment of the present disclosure isshown in a schematic flow chart. In this example, the secondary lens maybe implanted in a patient 138 having a pre-existing IOL that isoptically sub-optimal or otherwise doesn't meet the needs and desires ofthe patient. After the procedure starts 110, an attachment mechanism maybe formed in-situ in the pre-existing (base) IOL (step 140) using laseretching, for example, to form a groove as described previously.Formation of the groove may be performed within the perimeter of thepreviously cut capsulorhexis to avoid touching or otherwise disturbingthe lens capsule. The secondary lens may then be placed 116 on the baselens within the perimeter of the capsulorhexis, and the attachment meansmay be engaged 118 to connect the secondary lens to the base lens, andthe procedure may be completed 124 as described previously.

With reference to FIGS. 27-27D, an alternative modular IOL 270 is shownin front, sectional and detailed views, respectively. FIGS. 27A and 27Bshow cross-sectional views taken along line A-A and line B-B,respectively, in FIG. 27. FIGS. 27C and 27D show detail views of circleC in FIG. 27A and circle D FIG. 27B, respectively. Modular IOL 270 maybe configured similar to modular IOL 210 shown in FIGS. 21-21D. Likemodular IOL 210, modular IOL 270 includes a base 55 configured in theshape of an annulus or ring with a center opening and a recess defininga wall into which the correspondingly sized and shaped circular lens 65may be placed. Also like modular IOL 210, the wall defining the recessextends along the inside perimeter of the base 55, with a portionthereof milled down to define two diametrically opposed tabs 272. Theinside circumferential walls of the tabs 272 provide for a flush joint274 as seen in FIG. 27C, such that the anterior surface of the lens 65is flush with the anterior surface of the base 55. The interface of thejoint 274 along the tabs 272 may be canted, “S” shaped, or “C” shaped asshown, for example. Elsewhere along the perimeter, away from the tabs272, in the area where the wall is milled down, the perimeter edge ofthe lens 65 is exposed as seen in FIG. 27D, to facilitate insertion andremoval of the lens 65 by radial compression using forceps, for example.

Because the base 55 includes a center opening that is devoid ofmaterial, the base 55 may have a larger outside optic diameter(excluding haptics) of approximately 8 mm, for example, and still berolled into a delivery profile that is sufficiently small to fit througha corneal incision of less than approximately 2.4 mm, for example. Thismay allow at least a portion of the junction between the base 55 andlens 65 to be moved radially outward away from the circumferentialperimeter of the capsulorhexis, which typically has a diameter of 5-6mm. Moving at least a portion of the junction between the base 55 andthe lens 65 radially outward from the perimeter of the capsulorhexis mayreduce the amount of the junction that is in the field of view and thusreduce the potential for light scattering or optical aberrations (e.g.,dysphotopsias) created thereby.

To further illustrate this advantage, consider a standard (singlecomponent) IOL, which typically has an optic diameter of conventionallenses is 6 mm. An IOL with a 6 mm diameter optic may be rolled anddelivered through a 2.2 mm corneal incision. In order to secure thestandard IOL in the capsular bag, the capsulorhexis is typically sizedto allow the capsular bag to fully capture the standard IOL after thebag collapses and heals down. This drives surgeons to form acapsulorhexis having a diameter of approximately 4.5 mm to 5.5 mm.

Now consider IOL 270 by comparison. The modular (two piece) nature ofIOL 270 and the hole in the base 55 allow both components (base 55 andlens 65) to be rolled and delivered through a small corneal incision(e.g., 2.2 mm), but don't require a capsulorhexis of 4.5 mm to 5.5 mm.Rather, because the base has a diameter of 8 mm (excluding haptics), thecapsulorhexis diameter may be larger (e.g., 6.0 mm to 6.5 mm), whichallows the lens 65 to comfortably fit inside the perimeter of thecapsulorhexis and allows the junction 274 to be more peripheral tofurther minimize light scatter. Of course, notwithstanding theseexamples, any suitable dimensions may be selected to provide a gapbetween the lens 65 and the perimeter edge of the capsulorhexis in orderto mitigate the need to manipulate the lens capsule to connect ordisconnect the lens 65 to or from the base 55.

With reference to FIGS. 28A-28G, an alternative modular IOL 280 isshown. Modular IOL 280 may have dimensions as shown in the drawings byway of example, not necessarily limitation. Modular IOL 280 may be thesame or similar in terms of functions and advantages as other modularIOL embodiments described herein. Modular IOL 280 provides analternative interlocking feature used to connect the base and lens asdescribed in more detail hereinafter.

FIGS. 28A-28D show the base portion 55 of the modular IOL 280, and FIGS.28E-28G show the lens portion 65 of the modular IOL 280. Specifically,FIG. 28A shows a front view of the base 55, FIG. 28B shows across-sectional view taken along line B-B in FIG. 28A, FIG. 28C shows across-sectional view taken along line C-C in FIG. 28A, and FIG. 28Dshows a perspective view of the base 55. FIG. 28E shows a front view ofthe lens 65, FIG. 28F shows a cross-sectional view taken along line F-Fin FIG. 28E, and FIG. 28G shows a perspective view of the lens 65.

With specific reference to FIGS. 28A-28D, the base 55 portion of themodular IOL 280 includes a pair of haptics 54 and a center hole 57 suchthat all or a majority of the posterior optical surface of the lens 65is not in contact with the base 55 when the lens 65 is attached to thebase 55. A recessed ledge 282, which is sized and configured to receivethe lens 65, defines the perimeter of the hole 57. The ledge 282 mayinclude one or more keyed portions 284 that are sized and configured toreceive tabs 286 on the lens 65.

With specific reference to FIGS. 28E-28G, the lens 65 includes an opticportion 287 and one or more tabs 286, each with a thru hole 288. Tabs286 are sized to fit into the keyed portions 284 in the base. Moreparticularly, the tabs 286 may be aligned with the opening(discontinuity of the ledge 282) in the keyed portion 284 and movedposteriorly to rest against a lower portion 283 of the ledge 282 withinthe keyed portion 284. A probe or similar device may be used to engagethe hole 288 in the tab 286, and rotated (e.g., clockwise as shown) toslide the tab 286 in the keyed portion 284 until the tab 286 partiallyresides under an upper portion 285 of the ledge 282 within the keyedportion 284, thereby connecting the lens 65 to the base 55. Reversesteps may be followed to disconnect the lens 65 from the base 55.

With reference to FIGS. 29A-29F, an alternative modular IOL 290 isshown. Modular IOL 290 may have dimensions as shown in the drawings byway of example, not necessarily limitation. Modular IOL 290 may be thesame or similar in terms of functions and advantages as other modularIOL embodiments described herein. Modular IOL 290 provides analternative interlocking feature used to connect the base and lens asdescribed in more detail hereinafter.

FIGS. 29A-29C show the base portion 55 of the modular IOL 290, and FIGS.29D-29F show the lens portion 65 of the modular IOL 290. Specifically,FIG. 29A shows a front view of the base 55 having a body portion, FIG.29B shows a cross-sectional view taken along line B-B in FIG. 29A, andFIG. 29C shows a perspective view of the base 55. FIG. 29D shows a frontview of the lens 65, FIG. 29E shows a cross-sectional view taken alongline E-E in FIG. 29D, and FIG. 29F shows a perspective view of the lens65. The base portion 55 may not have an optic portion, allowing lens 65to be the sole optic portion of modular IOL 290.

With specific reference to FIGS. 29A-29C, the base 55 portion of themodular IOL 290 includes a pair of haptics 54 and a center hole 57 suchthat, except for the outermost portion, the posterior optical surface ofthe lens 65 is not in contact with the base 55 when the lens 65 isattached to the base 55. A recessed groove 292, which is sized andconfigured to receive tab portions 295 and 296 of the lens 65, definesthe perimeter of the hole 57.

Recessed groove 292 includes a lower rim 291 and an upper rim 293. Theupper rim 293 may have an inside diameter that is greater than theoutside diameter of the lens 65 such that the lens 65 can rest insidethe hole 57 of the base 55. All or a portion of the lower rim 291 mayhave an inside diameter that is less than the outside diameter of thelens 65 such that the lower rim 291 acts as a backstop for the lens 65when placed in the hole 57 of the base 55. By way of example, notnecessarily limitation, the upper rim 293 may have an inside diameter ofabout 6.0 mm, the lower rim 291 may have an inside diameter of about 5.5mm, and the lens 65 may have a diameter or longitudinal dimension(including tabs 295 and 296) of about 7.125 mm from the apex of tab 295to the apex of tab 296, as shown in FIG. 29D. Further, the optical bodyportion 297 may have an outside diameter of about 5.8 mm, as also shownin FIG. 29D. Further, as shown in FIG. 29B, the base may include athickness of about 0.615 mm. Also, the upper rim 293 may include alength of about 0.45 mm. The lower rim 291 may include an anteriorsurface having a length of about 0.55 mm and a posterior surface havinga length of about 0.75 mm.

The lower 291 and upper 293 rims defining the groove 292 may extendcontinuously around all or a portion of the perimeter of the hole 57.Alternatively, the lower 291 and upper 293 rims defining the groove 292may extend discontinuously around all or a portion of the perimeter ofthe hole 57. An example of a discontinuous arrangement is alternatingsegments of the lower 291 and upper 293 rims, which may lend itself wellto cryo-machining the base 55 in a single part. As shown, the base 55may be cryo-machined in two parts, including lower or posterior portion55A and upper or anterior portion 55B, that are subsequently bonded(e.g., adhesive or solvent bond), which may lend itself well to defininga continuous groove 292. To maintain chemical and mechanical propertycompatibility, the adhesive and the parts 55A/55B of the base 55 maycomprise the same monomeric or polymeric formulation. For example, theadhesive may be formulated from the same acrylic monomers used in makingthe hydrophobic acrylic parts 55A/55B of the base 55. Alternativemanufacturing methods well known in the art may also be employed.

Optionally, the base posterior portion 55A may be a solid disc, ratherthan an annular ring with a hole 57, thereby defining a posteriorsurface against which the posterior side of the lens 65 would contact.The posterior surface may be flat or curved to conform to the posteriorcontour of the lens 65. This may have the advantage of providing abackstop for the lens 65 thereby making delivery and positioning of thelens 65 in the base 55 easier. This may also provide the advantage ofreducing the rate of posterior capsular opacification.

With specific reference to FIGS. 29D-29F, the lens 65 of the modular IOL290 includes an optical body portion 297 (also referred to herein as“optic portion”) and one or more tabs 295 and 296. As shown in FIG. 29E,tab 296 may include a thickness of about 0.25 mm, and optic portion 297may include a maximum thickness of about 0.78 mm. The thickness of opticportion 297 may taper to tabs 295 and 296. As shown, tab 295 is fixed,whereas tab 296 may be actuated. As an alternative, fixed tab 295 may bereplaced with an actuatable tab (e.g., like tab 296). Fixed tab 295 mayinclude a thru hole 298 so that a probe or similar device may be used toengage the hole 298 and manipulate the tab 295. Hole 298 may include adiameter of about 0.231 mm. Actuatable tab 296 may be actuated between acompressed position for delivery into the hole 57 of the base 55, and anuncompressed extended position (shown) for deployment into the groove292 of the base 55, thus forming an interlocking connection between thebase 55 and the lens 65.

The outside curvature of the fixed tab 295 may have a radius conformingthe inside radius of the groove 292. Similarly, the outside curvature ofthe actuatable tab 296 may have a radius that conforms to the insideradius of the groove 292 when the actuatable tab 296 is in itsuncompressed extended position. This arrangement limits relativemovement between the base 55 and the lens 65 once connected.

Optionally, the lens 65 may be oval or ellipsoidal, rather thancircular, with the tabs 295 and 296 positioned adjacent the long axis.This arrangement would thus define a gap between the edge of the lens 65along its short axis and the inside perimeter of the upper rim 293 ofthe groove 292 in the base 55. The gap may have the advantage ofproviding access for a probe or similar device to pry apart the lens 65from the base 55 if separation were needed.

Actuatable tab 296 may be attached to and extend from the lens 65 at twoends with the middle portion free of the lens 65 (like a leaf spring) asshown. Alternatively, actuatable tab 296 may be attached to and extendfrom the lens 65 at one end with the other end free (like a cantileverspring). Other spring configurations may be employed as known in themechanical arts.

The actuatable tab 296 may elastically deform (e.g., by application ofan inward lateral force) to its compressed position. To facilitate lowforce compression, a dimple 299 may be provided on the outside (and/orinside) curvature of the tab to form a hinge in the spring.

FIGS. 29A2-29E2 show an alternative base portion 55 of the modular IOL290. Specifically, FIG. 29A2 shows a front view of the base 55, FIG.29B2 shows a cross-sectional view taken along line B-B in FIG. 29A2,FIG. 29C2 shows a perspective view of the base 55, FIG. 29D2 shows adetail view of circle D in FIG. 29B2, and FIG. 29E2 shows a detail viewof circle E in FIG. 29A2. In this alternative embodiment, all aspects ofthe base 55 of the modular IOL 290 are substantially the same except forthe provision of a pair of cutouts 291A, a pair of notches 293A, andsharp edge 291B.

By way of example, not necessarily limitation, the following dimensionsare provided. In FIG. 29A2, diameter A1 may be 13.00±0.02 mm, diameterA2 may be 8.50±0.10 mm, diameter A3 may be 7.00±0.051 mm, diameter A4may be 6.30±0.051 mm, diameter A5 may be 5.50+0.15/−0.05 mm, anddiameter A6 may be 7.92 mm. In FIG. 29B2, dimension B1 may be0.615±0.020 mm. In FIG. 29D2, dimension D1 may be 0.15 mm, dimension D2may be 0.17 mm, dimension D3 may be 0.75 mm, dimension D4 may be 0.35mm, dimension D5 may be 0.08 mm, and dimension D6 may be 0.30±0.02 mm.In FIG. 29E2, dimension E1 (width of cutouts 291A) may be 1.48 mm,dimension E2 (diameter at outer edge of notches 293A) may be 6.62 mm,dimension E3 (inside diameter of upper rim 293) may be 6.25 mm, anddimension E4 (radian of cutouts 291A) may be approximately 30 degrees.

As in the prior embodiment, the base 55 portion of the modular IOL 290in this alternative embodiment includes a pair of haptics 54 and acenter hole 57 such that, except for the outermost portion, theposterior optical surface of the lens 65 is not in contact with the base55 when the lens 65 is attached to the base 55. A recessed groove 292,which is sized and configured to receive tab portions 295 and 296 of thelens 65, defines the perimeter of the hole 57. The recessed groove 292includes a lower rim 291 and an upper rim 293.

In this alternative embodiment of the base 55 of modular IOL 290, thelower rim 291 may include one or more cutouts 291A, which aid inremoving visco-elastic intra-operatively. Also in this alternativeembodiment, the upper rim 293 may include one or more notches 293A toprovide access for a Sinskey hook intra-operatively, which allows thebase 55 to be more easily manipulated. Further in this embodiment, thelower rim 291 (or posterior side of base 55) may include at least onecorner edge 291B along its posterior perimeter to reduce the tendencyfor posterior capsular opacification. The corner edge 291B may be inaddition to corner edges formed along the anterior perimeter and theoutside perimeter of the base 55. For example, in the embodiment shown,the base 55 includes two edges along the outside perimeter, one anteriorperimeter edge, and one posterior perimeter edge 291B. In cross-section,the corner edge 291B may be defined by a square angle, an acute angle,or an obtuse angle. The corner edge 291B may be flush with the posteriorsurface as shown, or may protrude posteriorly. The base 55 may bemachined without subsequent tumbling to better form the edge 291B.

Note with reference FIGS. 29B, 29B2 and 29E that the lower rim 291 andthe upper rim 293 may define an anterior-posterior (AP) dimension aroundthe perimeter of the base 55 that is greater than the corresponding APdimension of the optic 65 adjacent the tabs 295, 296 that fit intogroove 292. For example, the AP dimension of the perimeter of the base55 may be 0.615 mm as shown in FIGS. 29B and 29B2, and the correspondingAP dimension of the optic 65 adjacent the tabs 295, 296 may be 0.25 mmas shown in FIG. 29E. When the modular IOL 290 is implanted in thecapsular bag, these relative dimensions provide a standoff between theposterior capsule and the posterior side of the optic 65, as well as astandoff between the anterior capsule adjacent the capsulorhexis(sometimes call anterior leaflets) and the anterior side of the optic.This standoff reduces the likelihood of cellular proliferation and thepotential for resulting opacification of the optic 65 and/or tissueadhesion to the optic 65 that might otherwise interfere withpost-operative optic exchange. Because such cellular proliferationtypically grows radially inward, the standoff may be provided adjacentthe perimeter of the optic 55 adjacent the inside circumference of thelower and upper rims 291, 293, whereas the center of the optic may ormay not have a standoff, with an AP dimension that is less than, thesame as or greater than the AP dimension around the perimeter of thebase 55. For example, the center of the optic may have an AP dimensionof 0.78 mm as shown in FIG. 29E (depending on the diopter), which isgreater than the AP dimension of the perimeter of the base 55 at 0.615mm as shown in FIGS. 29B and 29B2. Additionally, the lower (posterior)rim 291 may have a greater AP dimension than the upper (anterior) rim293 recognizing the cellular proliferation may be more likely on theposterior side than the anterior side due to the presence of thecapsulorhexis on the anterior side and the corresponding lower tissuecontact area on the anterior side. Those skilled in the art willrecognize the importance of the relative dimensions to achieve thiseffect rather than the specific dimensions, which are provided by way ofexample, not necessarily limitation.

With specific reference to FIGS. 29G-29J, implantation of a modular IOL290 is illustrated. As shown in FIG. 29G, the modular IOL 290 may beimplanted by initially delivering the base 55 into the capsular bag in arolled configuration using a delivery tube inserted through a cornealincision 13, through the capsulorhexis 36, and into the capsular bag 34.As shown in FIG. 29H, the base 55 may be ejected from the delivery tubeand allowed to unfurl. With gentle manipulation, the haptics 54 of thebase 55 engage the inside equator of the lens capsule 34 and center thehole 57 of the base 55 relative to the capsulorhexis 36.

The lens 65 may also be delivered in a rolled configuration using adelivery tube, positioning the distal tip thereof adjacent the base 55.The lens 65 may be ejected from the delivery tube and allowed to unfurl.With gentle manipulation, the lens 65 is centered relative to thecapsulorhexis 36. Once the base 55 has been delivered and unfurled inthe capsular bag, the lens 65 may be connected to the base 55 via anattachment mechanism 70. Modular IOL 290 uses tabs 295/296 and groove292 to provide an interlocking connection between the base 55 and thelens 65, comprising attachment mechanism 70.

As shown in FIGS. 29I-29J, the lens 65 may be connected to the base 55by first inserting the actuatable tab 296 into the groove 292. Theactuatable tab 296 may then be compressed by application of a lateralforce using a probe or similar device inserted into hole 298 of fixedtab 295, allowing the lens 65 to be advanced into the hole 57 of thebase 55 such that the lens 65 and base 55 are coplanar.

The compressive force may then be released from the actuatable tab 296,allowing the fixed tab 295 to slide into the groove 292 of the base 55,thus connecting the lens 65 to the base 55. By using a lateral force tocompress the interlocking feature rather than an anterior-posteriorforce, the risk of posterior rupture of the capsular bag is reduced. Theprobe may be removed from hole 298. Reverse steps may be followed todisconnect the lens 65 from the base 55.

The actuatable tab 296 and groove 292 may be described as interlockingmembers that provide an interlocking connection between the base 55 andthe lens 65, wherein at least one of the pair of interlocking members isactuatable to lock or unlock the connection therebetween. Moregenerally, one or more interlocking connections may be provided betweenthe base and lens. Each interlocking connection may include a pair ofinterlocking members, wherein one or both of the interlocking membersare actuatable. The actuatable interlocking member may be associatedwith the lens as described with reference modular IOL 290 in FIGS.29A-29F. Alternatively, the actuatable interlocking member may beassociated with the base 55 as described with reference to modular IOL300 shown in FIGS. 30A-30B.

Removing a lens, for example the lens 60/65, may present a challenge.The lens 60/65 may be detached from the primary component or base asdescribed herein, yet if the diameter of the unfurled lens 60/65 isgreater than the width of the corneal incision, removal through thecorneal incision may risk increasing the width of the corneal incision.This may increase the risk of damage to the cornea (or sclera if ascleral incision is used) and the likelihood of negative post-operativeresults. On the other hand, reducing the width of the lens 60/65, forexample by re-furling, may also require substantial manipulation andrisk damage to the capsular bag or the eye generally. Disclosed hereinare lens removal methods and tools to allow removal of a lens 60/65without increasing the width of the corneal incision and without damageto the eye or capsular bag. The lens removal methods and tools may beconfigured to minimize anterior-posterior forces and torque on the lensto prevent trauma or damage to the eye. The methods and tools may alsoavoid generating fragments, debris, or jagged edges.

Lens removal begins by disengaging a lens 60/65 from a base 50/55. Asshown in FIG. 29K, a probe or similar device may pass through thecorneal incision 13, capsulorhexis 36, and enter the capsular bag 34containing a modular IOL, for example modular IOL 290. As shown in FIG.29L, the probe or similar device may engage the hole 298 of fixed tab295 and compress the actuatable tab 296 by application of a lateralforce. Upon compression, fixed tab 295 may separate from groove 292 ofthe base 50/55. With gentle manipulation, the lens 60/65 may be liftedsuch that the lens 60/65 and base 50/55 are no longer coplanar. Oncefreed, the compressive force may then be released and the actuatable tab296 may elastically expand and separate from the groove 292 of the base50/55.

As shown in FIG. 29M, the probe or similar device may be used to passthe lens 60/65 from the capsular bag 34 into the anterior chamber 15.This step does not damage the eye or expand the size of thecapsulorhexis 36 because the width of the lens 60/65 is less than thewidth of the capsulorhexis 36. The probe or similar device may alsorotate the lens 60/65 into an orientation where the fixed tab 295 isproximal to the corneal incision 13 and the actuatable tab 296 is distalto the corneal incision 13.

A typical corneal incision 13 may have a width of about 2.2 mm, lessthan the outer diameter of the lens 60/65. Removing the lens 60/65 fromthe anterior chamber 15 through the corneal incision 13 may thus requiremechanical manipulation of the lens 60/65. The lens 60/65 may bemanipulated, for example cut, such that it can be pulled through thecorneal incision, either as a single piece or in multiple pieces. Acannula or delivery tube may facilitate this removal.

FIGS. 30A-30B show an alternative modular IOL 300 including a base 55and a lens 65. FIG. 30A shows a front view of the base 55, and FIG. 30Bshows a perspective view of the lens 65. The base 55 may include acenter hole 57 and a pair of haptics 54 as described previously. Base 55may also include one or more actuatable tabs 302 sized and configured tofit within a groove 304 in the lens 65. As shown, base 55 includes apair of actuatable tabs 302, although one of the tabs may be fixed(i.e., not actuatable). Lens 65 includes an optical portion 307 and oneor more grooves 304 defined by lower 303 and upper 305 rims. Because thelens 65 may be relatively thin around the perimeter where the groove 304resides, the grove 304 may be defined by extending the lower 303 andupper 305 rims as shown. As may be appreciated by those skilled in theart, the actuatable tabs 302 and grooves 304 in this embodiment may bethe same or similar to the actuatable tab 296 and groove 292 describedin the previous embodiment, including the same or similar function, use,variants and advantages.

With reference to FIGS. 31A-31B, a lens removal or extractor system 310for a modular IOL according to an embodiment of the present disclosureis shown schematically. FIG. 31A shows a perspective view of theextractor system 310 with the lens 60/65 captured, and FIG. 31B shows aperspective view of the extractor system 310 with the lens 60/65transected. The extractor system 310 is shown in a foreshortened viewfor purposes of illustration only. The length and diameter of theextractor system 310 may be selected for manual operation through aconventional corneal incision, such as the dimensions of a conventionallens cartridge.

The extractor system includes a handle 314 and a sleeve 312 extendingdistally therefrom. The sleeve 312 is hollow inside and includes atongue extension 313 to support the lens 60/65.

A grabber 316 extends distally from the sleeve 312 and is retractabletherein by an actuating member (not shown) extending proximally throughthe handle 314. The grabber 316 may include a distal hook, forceps orother mechanism to engage and pull the lens 60/65. In this example, thegrabber 316 engages the distal (opposite) edge of the lens 60/65.Alternatively, micro forceps may be used to grasp the proximal edge ofthe lens 60/65, or a sharp instrument may be used to penetrate theanterior surface of the lens 60/65 near the proximal edge. This can bedone safely as the sharp point is introduced through the sleeve 312 andthe extended tongue 313 protects eye anatomy.

A pair of blades 318 may extend slightly beyond the distal end of thesleeve 312 on opposite sides of the proximal end of the tongue extension313 as shown. Using blade actuator 319, the blades 318 may be advancedfor cutting as shown in FIG. 31A or retracted into sleeve 312 for nocutting as shown in FIG. 31B.

In use, with the lens 60/65 removed from the base in the capsular bag(not shown) and resident in the anterior chamber, the sleeve 312 may beinserted through the corneal incision, and the tongue extension 313 maybe positioned under the lens 60/65 to be extracted. The grabber 316 maythen be advanced over the lens 60/65. With the blades 318 extended forcutting, the grabber 316 may be retracted into the sleeve 312 to formcuts in the lens 60/65 that divide the lens into a center section andtwo lateral sections. The grabber 316 may be retracted until the cutsextend partially (e.g., 80%) across the diameter of the lens, thusretaining a connection between the center section and the two lateralsections. At this point, the blades 318 may be retracted using actuator319. The grabber 316 may then be retracted further, causing the centersection of the lens 60/65 to be pulled into the sleeve 312 and thelateral sections of the lens 60/65 to flip or rotate. Further retractionof the grabber 316 causes the lateral sections of the lens 60/65 tooverlap and follow the center section into the sleeve 312. The extractorsystem 310 may then be removed from the corneal incision, and the lens60/65 is thus extracted from the eye. The extractor system 310 may alsobe used to extract other optics, including optics with haptics, wherethe haptics follow the lateral sections into the sleeve.

With reference to FIGS. 31C-31F, a related embodiment of a lens removalor extractor system 310 for a modular IOL is shown schematically. FIG.31C shows a detailed perspective view of the extractor system 310 withthe lens 60/65 captured. FIG. 31D shows a detailed perspective view ofthe extractor system 310 with an extendable tongue 313 partiallyretracted and a lens 60/65 partially cut by a pair of blades 318. FIG.31E shows a perspective view of the extractor system 310 with a centerportion of lens 60/65 extracted into the lumen of hollow sleeve 312 andwith the remaining “horseshoe-shaped” lens 60/65 grasped between thesleeve 312 and the extendable tongue 313. FIG. 31F shows a schematicview of lens 60/65 after a center portion has been cut out andextracted. The length and diameter of the extractor system 310 may beselected for manual operation through a conventional corneal incision,such as the dimensions of a conventional lens cartridge.

The extractor system 310 may include a hollow cannula 312 with a pair ofdistally facing blades 318. The hollow cannula 312 may be sized andconfigured to extend through a corneal incision without increasing thesize of the incision. The hollow cannula 312 may have an oval orrectangular cross-section to facilitate extraction of lens 60/65 whileminimizing the size of the corneal incision. The hollow cannula 312 maybe formed of a rigid material and the blades 318 may be formed bysharpening the distal lateral edges of the cannula 312 with the cuttingedges formed on the inside of the cannula wall to avoid cutting oculartissue as it is passed through the corneal incision. The extractorsystem 310 may also include an extendable tongue 313 disposed in andextendable beyond the distal end of the hollow cannula 312. The distaltip of the extendable tongue 313 may form a grabber 316, for example adistal hook, forceps, or other mechanism to engage the lens 60/65.

The extendable tongue 313 may be configured to extend beyond the distalend of the cannula 312 and engage a far edge of the lens 60/65 in anextended position, and retract fully into the sleeve 312 in a retractedposition. In the retracted position, the grabber 316 at the distal tipof the extendable tongue 313 may protrude slightly from the sleeve 312.In an extended configuration (as shown), the extendable tongue 313 mayprovide a support surface for the lens 60/65 as it is being cut. Thegrabber 316 may engage the lens 60/65 through the hole formed betweenoptic portion 297 and actuatable tab 296 of modular IOL 290.

The tongue 313 moves relative to the hollow cannula 312 and pair ofblades 318, such that retraction of the tongue 313 towards the blades318 may be functionally equivalent to extension of the blades 318towards the tongue 313. This embodiment discloses cutting via retractionof the tongue 313 but should be understood to include extension of theblades 318.

In use, the lens 60/65 may be removed from the base in the capsular bag(not shown) and resident in the anterior chamber using methods describedherein. The sleeve 312 may be inserted through the corneal incision 13with the extendable tongue 313 in a retracted position. The extendabletongue 313 may be extended under (posterior to) the lens 60/65 and thegrabber 316 may engage the lens 60/65 through the hole formed betweenoptic portion 297 and actuatable tab 296 of modular IOL 290. For viewingpurposes, the extendable tongue 313 is shown below (posterior to) thelens 60/65, though it could also extend above the lens 60/65, or bothabove and below the lens 60/65.

As the extendable tongue 313 is retracted into the cannula 312, the lens60/65 is pulled along with and the pair of blades 318 and cuts the lensalong parallel cut paths 330. The cuts may extend from the fixed tab 295on the proximal side of lens 60/65, through the optic portion 297, andto the space between the optic portion 297 and actuatable tab 296. Thelens 60/65 is thus cut into two or more pieces. For example, as shown inFIGS. 31E-31F, the lens 60/65 may be cut into two pieces, with thecenter piece drawn into the hollow sleeve 312 and the remaining two“lobes” remaining in the anterior chamber. Thus, after cutting, theactuatable tab 296 may act as a connector for the two residual “lobes”of the lens 60/65. This may facilitate removal from the eye because onlya single connected piece remains in the anterior chamber after cutting.Furthermore, the notch 299 on actuatable tab 296 may act as a flexiblepoint of rotation such that the two “lobes” may flex and rotate relativeto one another, for example, during subsequent extraction from the eye.Alternatively, if the cut paths 330 were rotated ninety degrees relativeto the lens 60/65, the lens 60/65 would be cut into three pieces.

The blades 318 may be spaced apart to cut approximately one-third thediameter of the lens 60/65 to define three segments of roughly equalwidth that is less than the width of the corneal incision. For example,the segments may have a width of less than 2.0 mm to be removed througha 2.2 mm corneal incision. The width between the blades 318 may bedefined by the width of the cannula 312, which is sized for insertionthrough the corneal incision without increasing the size of theincision. Thus, each of the three segments is also sized for removalthrough the corneal incision without increasing the size of theincision. The segments may be removed serially in individual pieces orinterconnected pieces using an uncut portion of the lens 60/65 toconnect the pieces. As shown, a generally rectangular-shaped centerportion is cut (first segment) leaving a horseshoe-shaped portion 340(second and third segment or “lobes” connected by actuatable tab 296).By way of example, not necessarily limitation, the following dimensionsare provided. In FIG. 31F, dimension F₁ may be 1.950 mm and dimension F₂may be 1.900 mm.

A notch or other feature in the lens 60/65 may help to position theextendable pair of blades 318 on the center of the lens. For example,the space between the optic portion 297 and the actuatable tab 296 maybe sized such that lateral motion of the grabber 316 is restricted,centering the extractor system 310 relative to the lens 60/65.

The cutting step may apply substantially balanced forces (minimal to nonet force) on the lens 60/65. The blades 318 may apply forces on thelens 60/65 as it cuts. These forces may be opposed by bracing forcesapplied by the extendable tongue 313 and grabber 316. This minimizes oravoids net forces on the lens 60/65, preventing trauma and damage to thecapsular bag. Alternative cutting mechanisms are possible. A pair ofcircular blades (“pizza cutters”) attached to an extendable arm andconfigured to roll along cut path 330 may replace blades 318. In anotherembodiment, the pair of blades 318 may cut the lens 60/65 by applying adownward compressive force (“cookie cutter”), balanced by an upwardcompressive force from the extendable tongue 313.

After cutting the lens 60/65, the extendable tongue 313 may retract intothe sleeve 312, extracting the center portion into the sleeve 312. Theextractor system 310 may then grasp the horseshoe portion 340 betweenthe grabber 316 and the upper or lower edges of the cannula between theblades 318, as shown in FIG. 31E. The extractor system 310 may be pulledfrom the eye through the corneal incision 13, thereby removing the lens60/65. Alternatively, a forceps or other appropriate surgical tool maygrasp the horseshoe portion 340 and extract it from the anterior chamber15 of the eye through the corneal incision 13. The horseshoe portion 340may flex as it is extracted, similar to the extraction shown in FIG.32D. The extractor system 310 may also be used to extract other optics,including optics with haptics, where the haptics follow the lateralsections into the sleeve.

With specific reference to FIGS. 31G-31N, an alternative embodiment of alens removal or extractor system 310 for a modular IOL is shownschematically. FIG. 31G shows a detailed perspective view of theextractor system 310 with the lens 60/65 captured by anextendable/retractable grabber 320. FIG. 31H shows a detailedperspective view of the extractor system 310 with anextendable/retractable hollow cannula 312 fully extended relative tograsper 320 that is grasping a lens 60/65 cut by a pair of blades 318.FIG. 31I shows a transparent view of the extractor system 310. FIG. 31Jshows a zoom-in view of the extendable/retractable grasper 320 with lens60/65 captured. FIG. 31K shows a zoom-in view of the grasper 320 infully retracted and closed configuration within hollow cannula 312. FIG.31L shows a zoom-in view of the grasper 320 in fully extended and openconfiguration outside of hollow cannula 312. FIG. 31M shows a relatedembodiment of a grasper 320 having a rectangular cross-section. FIG. 31Nshows a related embodiment of a grasper 320 having four prongs. Thelength and diameter of the extractor system 310 may be selected formanual operation through a conventional corneal incision, such as thedimensions of a conventional lens cartridge.

As shown in FIGS. 31G-31H, the extractor system 310 has anextendable/retractable hollow cannula 312 having a pair of distallyfacing blades 318 at the distal end and a circular base 360 at theproximal end. The hollow cannula 312 may have an oval or rectangularcross-section to facilitate extraction of lens 60/65 while minimizingthe size of the corneal incision. The extractor system 310 has anextendable/retractable grasper 320 that can extend and retract relativeto hollow cannula. The grasper 320 is connected to a “T-shaped” handle350 such that when the handle 350 slides distally or proximally, thegrasper 320 extends distally or proximally, respectively. As shown inFIG. 31I, a spring 370 facilitates the extension/retraction of thecannula 312 relative to the grasper 320. The spring 370 is locatedproximal to handle 350 and distal to circular base 360 and is configuredto bias the grasper 320 in an extended configuration and the cannula 312in a retracted configuration.

As shown in FIG. 31J, the grabber 320 has an upper arm 322 and a lowerarm 324. The top surface of the upper arm 322 and the bottom surface ofthe lower arm 324 are both generally smooth. The bottom surface of theupper arm 322 and the top surface of the lower arm 324 may both havesurfaces configured to facilitate grasping, for example serratedsurfaces. The serrated surface may have a plurality of teeth 326. Theangle of teeth 326 may be configured with a proximal bias to furtherfacilitate grasping the lens 60/65 during cutting and/or retraction.

The grabber 320 may articulate between an open configuration and aclosed grasping configuration. As shown in FIG. 31K, when the grabber320 is fully retracted within the cannula 312, it is in a closedconfiguration with the upper arm 322 having a slight downward angle suchthat the distal end of the upper arm 322 touches the distal end of lowerarm 324. This pinched tip may facilitate corneal entry.

As shown in FIG. 31L, when the grabber 320 is fully extended from thecannula 312, it articulates to an open configuration. In the openconfiguration, the upper arm 322 has two flex points 328 that bias theupper arm 322 into the open configuration when the cannula 312 isretracted. The lower arm 324 remains flat and parallel to the cannula312. In this open configuration, the distal portion of upper arm 322 isparallel to lower arm 324 and the opening is wide enough to accommodatea lens 60/65. This parallel-arm open configuration allows a maximumnumber of serrated teeth 326 to contact the lens 60/65 simultaneouslywhen the cannula 312 and blade 318 extend to close the grabber 320. Thisalso minimizes the opening distance which keeps the upper arm 322 andlower arm 324 away from the cornea while still allowing the lens 60/65to slide into the opening. The grabber 320 may be made of any suitablematerial to create this biased configuration of the upper arm 322 whenit is outside the cannula 312, for example, shape-memory polymers,non-shape-memory polymers, metals, alloys, stainless steel, heat-setnitinol, elastic materials, or super-elastic materials.

As shown in FIG. 31M, the grabber 320 may have a rectangularcross-section. As shown in FIG. 31N, the grabber 320 may have fourprongs, two upper prongs 322 and two lower prongs 324. These embodimentsof the grabber 320 function almost identically to previously disclosedgrabber 320.

In use, the lens 60/65 may be removed from the base in the capsular bag(not shown) and resident in the anterior chamber using methods describedherein. The cannula 312 may be inserted through the corneal incision 13with the “T-shaped” handle 350 in a proximal configuration and,accordingly, the grasper 320 retracted within the cannula 312, as shownin FIG. 31K. The handle 350 may be slowly released and the spring 370may extend the grasper 320 out from the distal end of cannula 312. Theupper arm 322 and lower arm 324 may open into a parallel configuration.The grasper 320 may encompass the lens 60/65, as shown in FIG. 31L.

During the cutting step, it may be preferable to extend the cannula 312and blades 318 distally towards the lens, as opposed to pulling thegrasper 320 proximally towards the blades 318, because it prevents thelens 60/65 from hitting the angle of the eye and keeps the lens 60/65centered in a user's view. The grasper 320 may remain stationary whilethe spring 370 is compressed by handle 350, extending cannula 312 andblades 318 towards the lens 60/65. As the cannula 312 extends distally,it encompasses the grabber 320, closing the upper arm 322 and lower arm324 around the lens 60/65. As the grabber 320 closes, a maximum numberof serrated teeth 326 contact the lens 60/65 simultaneously to increasegrip. As blades 318 cut into the lens 60/65, the grabber 320 is directlyadjacent to the blades 318. Gripping the lens 60/65 directly adjacent tothe blades 318 as they cut provides stability, preventing the lens 60/65from tearing, twisting, bowing, or crimping.

The cannula 312 and blades 318 may continue to extend towards the distalend of the lens 60/65 along cut path 330. As shown in FIG. 31F, the cutpath 330 may extend from the fixed tab 295 on the proximal side of lens60/65, through the optic portion 297, and to the space between the opticportion 297 and actuatable tab 296. As described previously, aftercutting, the actuatable tab 296 may act as a connector for the tworesidual “lobes” of the lens 60/65. This may facilitate removal from theeye because only a single piece remains in the anterior chamber.Furthermore, the notch 299 on actuatable tab 296 may act as a flexiblepoint of rotation such that the two “lobes” may flex and rotate relativeto one another, for example, during extraction from the eye.

As shown in FIG. 31I, after the cut is complete, the handle 350 hascompressed spring 370 and the grasper 320 is retracted within thecannula 312 along with the center portion of lens 60/65. The extractorsystem 310 may be removed from the anterior chamber and eye,simultaneously removing the center cut portion of lens 60/65. Theremaining portion or portions of lens 340 may be removed from the eyeusing disclosed methods.

In another embodiment, the lens 60/65 of an IOL may be removed from theeye 10 in multiple pieces using a surgical punch 430 cutting tool. Asshown in FIG. 32A, the surgical punch 430 may be scissors-like, having aproximal spring 475 to bias the punch in the normally open position, aproximal handle region 480, a distal hinge 470, and a distal narrowpunch 440. The distal narrow punch 440 may be configured to fit within acorneal incision, for example having tapered shape with across-sectional width of less than about 2.2 mm. This may facilitateinsertion of the distal narrow punch 440 through the corneal incision 13and into the anterior chamber 15.

The distal narrow punch portion 440 may have an inner blade 450 and anouter blade 460 attached at the distal hinge 470. The inner blade 450and outer blade 460 may be configured to separate from one another in a“jaw-like” manner. The inner blade 450 may be configured to fit insidethe outer blade 460 such that when the surgical punch is compressed, anymaterial caught between the inner blade 450 and outer blade 460 is cutout, for example a center portion of a lens 60/65. The shape of the cutin the material may be substantially similar to the shape of the innerblade 450 that overlaps the material when cut. An inner blade shaft 455may extend proximally from the inner blade 450. An outer blade shaft 465may extend proximally from the outer blade 460. Inner blade shaft 455and outer blade shaft 465 may each have a gripping region 485 andconnect at the proximal hinge 475.

As shown in FIG. 32B, the distal narrow punch 440 of surgical punch 430may enter the anterior chamber 15 through a corneal incision 13 andgrasp a lens 60/65 of an IOL 290. The distal narrow punch 440 may enterthe anterior chamber 15 in a compressed or closed configuration. Onceinside the anterior chamber 15, the surgical punch may expand to an“open jaw” configuration where the inner blade 450 and outer blade 460can be configured to encompass a center portion of the lens 60/65. Thesurgical punch 430 may be compressed, closing the “jaw” of the narrowpunch portion 440 and returning the inner blade 450 and outer blade 460to a closed configuration. This compression may cut the center portionof the lens 60/65. Compression of the surgical punch 430 may applyopposing forces on the lens 60/65 such that the forces applied to thelens 60/65 are balanced (i.e., no net force on the lens 60/65). Thus,compression does not apply substantial force in the anterior orposterior directions and does not damage the capsular bag.

The surgical punch 430 may be extracted from the anterior chamber 15 viathe corneal incision 13. The center portion of the lens 60/65, havingsubstantially the same shape as a portion of the inner blade 450, mayalso fit through the corneal incision 13. Thus, as the surgical punch430 is extracted, the center portion may be simultaneously extractedfrom the anterior chamber 15 through the corneal incision 13.Alternatively, the center portion may be extracted from the anteriorchamber 15 through the corneal incision 13 with another appropriatesurgical instrument, for example forceps 235 having a pair of atraumaticgrasping tips 237 and a tubular shaft 239, as described previously.

With specific reference to FIG. 32C, a modular IOL 290 is shown with acenter portion removed, leaving behind a concave horseshoe portion 420of the lens 60/65. Both the center portion and the remaining horseshoeportion 420 of the lens 60/65 may be narrow enough at all points to fitthrough the corneal incision, for example less than 2.0 mm in width atall points. The center portion may comprise portions of fixed tab 295,hole 298, and optic portion 297. It may be preferable for the centerportion to include portions of the fixed tab 295, as opposed to portionsof actuatable tab 296. Cutting the actuatable tab 296 with a surgicalpunch 430 may create a small third piece comprising a fragment of theactuatable tab 296, possibly containing the dimple 299. Such a fragmentmay be difficult to see or extract. Thus, in this embodiment, the centerportion extends past the halfway point of the optic 297, but does notextend to actuatable tab 296. By way of example, not necessarilylimitation, the following dimensions are provided. In FIG. 32C dimensionC₁ may be 5.8 mm, dimension C₂ may be 0.75 mm, dimension C₃ may be 1.69mm, and dimension C₄ may be 6.92 mm.

As shown in FIG. 32D, the horseshoe portion 420 of the lens 60/65 may beremoved through the corneal incision 13. The width of the horseshoeportion 420 at any point may be less than the width of the cornealincision, for example 2.0 mm. This may be referred to as a maximum widthof 2.0 mm. Thus, the horseshoe portion 420 may be narrow enough at allpoints to fit through the corneal incision (typically 2.2 mm) withoutincreasing its size. Forceps 235 may be inserted through the cornealincision, into the anterior chamber 15, and used to grasp the horseshoeportion 420 of the lens 60/65. With gentle manipulation, the forceps 235may rotate and pull the horseshoe potion 420 of the lens 60/65 out ofthe anterior chamber 15 through the corneal incision 13. Special caremay be taken such that extraction of the horseshoe portion 420 of thelens 60/65 does not enlarge the corneal incision 13. After extraction,the base 50/55 of modular IOL 290 may remain in the capsular bag 34.

In another embodiment, a cutting instrument may be used to produce acurved cut 510 (“spiral cut”) in the lens 60/65 while the lens 60/65remains one unit and is not cut into multiple pieces. With specificreference to FIG. 33A, a modular IOL 290 is shown having a curved cut510. As shown, the curved cut 510 may extend from the fixed tab 295,into the optic portion 297, past the halfway point of the optic 297, butnot extend to actuatable tab 296. The curved cut 510 may bisect the hole298 of fixed tab 295 of the lens 60/65.

The curved cut 510 may be configured on the lens 60/65 such that thedistance from any point on the curved cut 510 to the nearest point onthe perimeter of lens 60/65 is less than the width of the cornealincision 13, for example less than 2.0 mm. This may be referred to as amaximum width of 2.0 mm. This may facilitate extraction of the lens60/65 having curved cut 510 from the anterior chamber 15 through thecorneal incision 13 (typically 2.2 mm).

The curved cut 510 may be created using any appropriate cutting tool,for example a curved micro-scissors 530 having a distal cutting portion540 shown in FIG. 33B. FIG. 33B is a detailed schematic of the distalcutting portion 540. The distal cutting portion 540 of the curvedmicro-scissors 530 may have an inner blade 550 and an outer blade 560attached at the distal hinge 570. The distal cutting portion 540 may beconfigured to fit within a corneal incision 13, for example having across-sectional width of less than about 2.0 mm. This may facilitateinsertion of the distal cutting portion 540 through the corneal incision13 and into the anterior chamber 15. Proximal to the distal cuttingportion 540 is a body portion (not shown) that may be substantiallysimilar to the proximal handle region 480 of surgical punch 430,including a distal hinge.

The inner blade 550 and outer blade 560 may be configured to open andclose in a “jaw-like” manner. Similar to the blades of an ordinary pairof scissors, the inner blade 550 and outer blade 560 may be configuredto cut any material caught between the blades when the curvedmicro-scissors 530 is compressed or closed. As shown in FIG. 33C, thecurved micro-scissors 530 may make a curved cut 510 in a lens 60/65where the cut path is substantially similar to the shape between theinner blade 550 and outer blade 560.

Compression of the curved micro-scissors 530 may apply opposing forceson the lens 60/65 such that forces applied to the lens 60/65 arebalanced (i.e., the net force on the lens 60/65 is approximately zero).Additionally, the curvature of the curved micro-scissors 530 also avoidsunwanted torque or rotation of the lens 60/65. Whereas a straightscissors may apply a torque to a lens as it cuts causing rotation of thelens, any torque on the lens 60/65 from the inner blade 550 and outerblade 560 is counterbalanced by an equal opposite torque on the lens60/65 at another point of contact on the curved blades. Thus, cuttingthe lens 60/65 does not apply substantial force or torque in theanterior or posterior directions and does not damage the capsular bag.

Referring again to FIG. 33C, the curved micro-scissors 530 is showngrasping a lens 60/65 of an IOL 290. This configuration could be withinthe anterior chamber 15 of an eye 10 having a corneal incision 13. Usingthe methods described above with reference to a surgical punch 430, thedistal cutting portion 540 of curved micro-scissors 530 may be partiallyinserted through a corneal incision 13 and into the anterior chamber 15.Since the cross-sectional width of the distal curved blades 540 is lessthan the width of the corneal incision 13, the size of the cornealincision 13 is unchanged.

The distal cutting portion 540 may enter the anterior chamber 15 in aclosed configuration. Once inside the anterior chamber 15, the innerblade 550 and outer blade 560 may open into an expanded configurationfor cutting the lens 60/65 along curved cut path 510. The distal cuttingportion 540 may compress and close on the lens 60/65 to create curvedcut 510, beginning by cutting the fixed tab 295, extending into theoptic portion 297 past the halfway point, then curving back towards thefixed tab 295 without reaching the actuatable tab 296. Curved cut 510may bisect hole 298 in fixed tab 295.

After cutting the lens 60/65, the curved micro-scissors 530 may beextracted from the anterior chamber 15 via the corneal incision 13. Thelens 60/65 with curved cut 510 may be extracted from the anteriorchamber 15 through the corneal incision 13 with an appropriate surgicalinstrument, for example forceps 235 having a pair of atraumatic graspingtips 237 and a tubular shaft 239, as described previously.

As the lens 60/65 is extracted, it may extend into a helicalconfiguration. Similar to the extended horseshoe configuration of FIG.32D, FIG. 33D shows a lens 60/65 having curved cut 510 in an extendedhelical configuration. The lens 60/65 may extend in a helical mannerduring extraction from the anterior chamber 15 through the cornealincision 13. The lens 60/65 achieves this helical configuration when apulling force is applied to either a proximal grasping point 515 or adistal grasping point 520.

Forceps 235 may be inserted through the corneal incision 13, into theanterior chamber 15, and used to grasp the lens 60/65, for example atthe proximal grasping point 515 or distal grasping point 520. Withgentle manipulation, the forceps 235 may rotate and pull the lens 60/65with curved cut 510 out of the anterior chamber 15 through the cornealincision 13. Special care may be taken such that extraction of the lens60/65 does not enlarge the corneal incision 13. As described above, thelens 60/65 with curved cut 510 may be narrow enough at all points to fitthrough the corneal incision. The distance from any point on the curvedcut 510 to the nearest perimeter point of the lens 60/65 may be lessthan the width of the corneal incision 13, for example less than 2.0 mm.This may be referred to as a maximum width of less than 2.0 mm.

The foregoing discussion of the invention has been presented forpurposes of illustration and description. The foregoing is not intendedto limit the invention to the form or forms disclosed herein. Althoughthe description of the invention has included description of one or moreembodiments and certain variations and modifications, other variationsand modifications are within the scope of the invention, e.g., as may bewithin the skill and knowledge of those in the art, after understandingthe present disclosure. It is intended to obtain rights which includealternative embodiments to the extent permitted, including alternate,interchangeable and/or equivalent structures, functions, ranges or stepsto those claimed, whether or not such alternate, interchangeable and/orequivalent structures, functions, ranges or steps are disclosed herein,and without intending to publicly dedicate any patentable subjectmatter.

We claim:
 1. A method for removing at least a portion of an intraocularlens disposed in a lens capsule of an eye having an anterior chamber,comprising: a. moving the portion of the intraocular lens from the lenscapsule to the anterior chamber; b. inserting a cutting tool into theanterior chamber; c. making a single cut motion with the cutting tool tosimultaneously form two spaced-apart cut lines in the portion of theintraocular lens to form cut pieces, wherein forming the twospaced-apart cut lines forms first, second, and third cut pieces, thefirst cut piece being entirely disconnected from the second and thirdcut pieces, and wherein the second and third cut pieces are connected byan uncut portion of the intraocular lens to form a hinge between thesecond and third cut pieces; and d. removing the cut pieces from theeye.
 2. A method as in claim 1, wherein the portion of the intraocularlens and the cut pieces have a lateral width, and wherein the lateralwidth of the cut pieces is less than half the lateral width of theportion of the intraocular lens.
 3. A method as in claim 1, wherein thetwo spaced-apart cut lines are made by spaced apart blades of thecutting tool.
 4. A method as in claim 1, further comprising grasping theportion of the intraocular lens with the cutting tool before cutting theportion of the intraocular lens, wherein grasping the portion of theintraocular lens with the cutting tool includes decreasing a size of agap between a first arm of the cutting tool and a second arm of thecutting tool to grasp the portion of the intraocular lens with the firstand second arms of the cutting tool, and wherein at least a portion ofthe first arm extends parallel to at least a portion of the second arm.5. A method as in claim 1, wherein the intraocular lens includes anoptic portion connected to a base portion, the method furthercomprising: disengaging the optic portion from the base portion withinthe lens capsule; moving the optic portion from the lens capsule to theanterior chamber while leaving the base portion in the lens capsule; andforming the two spaced-apart cut lines in the optic portion.
 6. A methodas in claim 1, wherein simultaneously forming the two spaced-apart cutlines includes simultaneously forming the two spaced-apart cut lines onopposite sides of the first cut piece.
 7. A method for removing at leasta portion of an intraocular lens disposed in a lens capsule of an eyehaving an anterior chamber, comprising: a. moving the portion of theintraocular lens from the lens capsule to the anterior chamber; b.inserting a cutting tool into the anterior chamber; c. making a singlecut motion with the cutting tool to form two spaced-apart cut lines inthe portion of the intraocular lens to form cut pieces, wherein formingthe two spaced-apart cut lines forms first, second, and third cutpieces, the first cut piece being entirely disconnected from the secondand third cut pieces, and wherein the second and third cut pieces areconnected by an uncut portion of the portion of the intraocular lens toform a hinge between the second and third cut pieces; and d. removingthe first, second, and third cut pieces from the eye.
 8. A method as inclaim 7, wherein removing the first, second, and third cut pieces fromthe eye includes removing the second and third cut pieces from the eye,while the second and third cut pieces are connected by the uncutportion, after removing the first cut piece from the eye.